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      • id216
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      • abstract_of_study<p align=\"left\">\n <font face=\"TimesNewRoman\">Intermittent preventive treatment of </font><i><font face=\"TimesNewRoman,Italic\">falciparum </font></i><font face=\"TimesNewRoman\">malaria in pregnant women (IPTp).</font></p>\n<p align=\"left\">\n <b><font face=\"TimesNewRoman,Bold\">Background and Rationale</font></b></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">Malaria is a serious protozoal infection caused by any of the five species of </font><i><font face=\"TimesNewRoman,Italic\">Plasmodia </font></i><font face=\"TimesNewRoman\">and</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">transmitted by anopheline mosquitoes; it continues to be one of the largest global health</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">problems.</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">1 2 </font></font><font face=\"TimesNewRoman\">As per the World Health Organization (WHO) </font><i><font face=\"TimesNewRoman,Italic\">World Malaria Report </font></i><font face=\"TimesNewRoman\">2009,</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">3</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">about half of the world's population is at risk of infection in 108 endemic countries and</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">territories. In 2008, there were an estimated 243 million cases and 863,000 malaria-related</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">deaths.</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">3 </font></font><font face=\"TimesNewRoman\">Malaria in pregnancy (MIP) is one of the most common causes of preventable</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">mortality and morbidity in pregnant women and infants in sub-Saharan Africa. An estimated</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">30 million pregnancies are at risk of malaria infection in sub-Saharan Africa each year;</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">4</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">about 200,000 infants and 10,000 women die of malaria in pregnancy each year.</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">5</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">Important progress has been made in the control of malaria in pregnancy in Africa with the</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">introduction of intermittent preventive treatment in pregnancy (IPTp). The WHO</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">recommends the administration of IPTp with sulfadoxine-pyrimethamine (SP) during</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">antenatal visits in high malaria transmission areas of sub-Saharan Africa.</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">6 </font></font><font face=\"TimesNewRoman\">However, SP</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">resistance has become widespread especially in East and Southern Africa, greatly limiting the</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">protective effect of IPTp with SP. The development of safe, efficacious and affordable</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">replacement of SP for IPTp is an urgent priority.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">The combination of azithromycin (AZ) and chloroquine (CQ) could potentially replace</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">SP for IPTp. AZ and CQ are synergistic in vitro and in vivo against CQ resistant strains of</font></p>\n<p align=\"left\">\n <i><font face=\"TimesNewRoman,Italic\">P. falciparum</font></i><font face=\"TimesNewRoman\">. Co-administration of AZ and CQ has demonstrated efficacy, safety and</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">tolerability in two multi-country Phase 3 clinical studies (A0661134 and A0661155) in the</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">treatment of symptomatic uncomplicated malaria in non-pregnant adults in sub-Saharan</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">Africa. AZ and CQ have been on the market for several years and have extensive safety</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">records in adults, children and pregnant women. Both AZ and CQ have been widely used in</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">all trimesters of pregnancy and are considered safe in pregnant women as individual agents.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">In high-income countries, AZ is commonly used to treat and prevent sexually transmitted</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">infections (STIs) including </font><i><font face=\"TimesNewRoman,Italic\">Neisseria gonorrhoeae </font></i><font face=\"TimesNewRoman\">and </font><i><font face=\"TimesNewRoman,Italic\">Chlamydia trachomatis </font></i><font face=\"TimesNewRoman\">infections. In</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">sub-Saharan Africa, two randomized controlled clinical trials.</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">21, 22 </font></font><font face=\"TimesNewRoman\">found that a single dose of</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">1000 mg AZ was comparable to benzathine penicillin G in curing syphilis. The incidence of</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">adverse fetal outcomes has been shown to be reduced by about 30% when these three STIs</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">were treated in pregnancy.</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">23 </font></font><font face=\"TimesNewRoman\">In addition, AZ has also demonstrated protective effect against</font></p>\n<p align=\"left\">\n <i><font face=\"TimesNewRoman,Italic\">Trichomonas vaginalis </font></i><font face=\"TimesNewRoman\">when used as chemoprophylaxis</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">24 </font></font><font face=\"TimesNewRoman\">and reduced the risk of preterm</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">delivery attributable to </font><i><font face=\"TimesNewRoman,Italic\">T. vaginalis</font></i><font face=\"TimesNewRoman\">, even in the second trimester when first-line treatment,</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">metronidazole, should be avoided.</font><font face=\"TimesNewRoman\" size=\"1\"><font face=\"TimesNewRoman\" size=\"1\">25</font></font></p>\n<p align=\"left\">\n <font face=\"Helvetica\">090177e1811d3ccb\\Approved\\Approved On: 19-Feb-2010 20:59</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\" size=\"2\"><font face=\"TimesNewRoman\" size=\"2\">Azithromycin/Chloroquine Combination</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\" size=\"2\"><font face=\"TimesNewRoman\" size=\"2\">A0661201</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\" size=\"2\"><font face=\"TimesNewRoman\" size=\"2\">Final Protocol, 14 February 2010</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\" size=\"2\"><font face=\"TimesNewRoman\" size=\"2\">PFIZER CONFIDENTIAL</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\" size=\"2\"><font face=\"TimesNewRoman\" size=\"2\">Page 3</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">A fixed dose combination tablet formulation of AZ and CQ (AZCQ, 250 mg AZ/155 mg</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">CQ base) has been developed specifically for the IPTp indication and will be evaluated in</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">IPTp studies. In a clinical pharmacology study A0661186, AZCQ administration resulted in</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">the systemic exposures to AZ, CQ and des-ethyl CQ (an active metabolite of CQ) at levels</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">comparable to those achieved following administration of commercial standalone tablets of</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">AZ (Zithromax) and CQ (Aralen) evaluated in adult treatment studies.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">A Phase 3 randomized controlled clinical study to demonstrate the superiority of AZCQ IPTp</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">regimen over SP IPTp regimen is planned in East and Southern sub-Saharan Africa where SP</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">resistance is emerging as an issue and where SP is the current standard of care for IPTp. This</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">will be the pivotal study for regulatory submissions to European Medicines Agency (EMA)</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">and to the national regulatory agencies in Sub-Saharan African countries.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">AZCQ is expected to exert IPTp effect through multiple mechanisms including peripheral</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">parasitological clearance in pregnant women, prevention of re-infections,</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">prevention/treatment of placental malaria and prevention/treatment of STIs. The relative</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">contributions of these mechanisms towards IPTp effect are not yet known. The study</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">A0661201 is an open label, non-comparative parasitological clearance study of a single</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">3-day treatment course of AZCQ in about 166 pregnant women in second and third trimesters</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">of pregnancy with asymptomatic parasitemia. This study will help to characterize the</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">magnitude of parasitological clearance required for the IPTp effect observed in A0661158</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">study, and will serve as a supportive study in IPTp regulatory dossier. A0661201 study will</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">also evaluate pharmacokinetic (PK) exposures, of both AZ and CQ in pregnant women</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">following administration of a single 3-day treatment course of AZCQ. Subjects will be</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">followed up to Day 42 after the first dose, and followed through delivery or to pregnancy</font></p>\n<p>\n <font face=\"TimesNewRoman\">termination for safety assessments of Exposure in Utero (EIU).</font></p>\n
      • study_title<p align=\"left\">\n <b><font face=\"TimesNewRoman,Bold\">A0661201</font></b></p>\n<p align=\"left\">\n <b><font face=\"TimesNewRoman,Bold\">AN OPEN LABEL, NON-COMPARATIVE STUDY TO EVALUATE </font></b><b><font face=\"TimesNewRoman,Bold\">PARASITOLOGICAL CLEARANCE RATES AND PHARMACOKINETICS OF </font></b><b><font face=\"TimesNewRoman,Bold\">AZITHROMYCIN AND CHLOROQUINE FOLLOWING ADMINISTRATION OF </font></b><b><font face=\"TimesNewRoman,Bold\">A FIXED DOSE COMBINATION OF AZITHROMYCIN AND CHLOROQUINE </font></b><b><font face=\"TimesNewRoman,Bold\">(AZCQ) IN ASYMPTOMATIC PREGNANT WOMEN WITH PLASMODIUM</font></b><b><font face=\"TimesNewRoman,Bold\">FALCIPARUM PARASITEMIA IN SUB-SAHARAN AFRICA</font></b></p>\n
      • laymans_summary(null)
      • short_titleA0661201
      • protocol_noECCT/10/09/03
      • version_noVesrion 1 Final 14 February 2010
      • date_of_protocol14-02-2010
      • study_drugAzithromycin/Chloroquine Combination
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameAZCQ
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkimani@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
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      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
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      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Joshua Kimani; University of Nairobi Institute of Tropical and Infectious Diseases, College of Health Sciences, University of Nairobi, Nairobi & Siaya County Referral Hospital, Siaya, Kenya
      • declaration_date121-02-2014
      • declaration_principal_investigatorDr Joshua Kimani, University of Nairobi Institute of Tropical and Infectious Diseases, College of Health Sciences, University of Nairobi, Nairobi, Kenya & Siaya County Referral Hospital, Siaya, Kenya
      • declaration_date221-02-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p align=\"left\">\n <font face=\"TimesNewRoman\">1. Primigravidae and secundigravidae pregnant women at </font><font face=\"Symbol\" lang=\"ZH-TW\"></font><font face=\"TimesNewRoman\">14 and </font><font face=\"Symbol\" lang=\"ZH-TW\">ï‚£</font><font face=\"TimesNewRoman\">30 weeks of</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">gestational age (confirmed by ultrasound examination).</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">2. Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection </font><font face=\"TimesNewRoman\">(confirmed by microscopy) with parasite counts in the range of 80-100,000/</font><font face=\"Symbol\" lang=\"ZH-TW\"></font><font face=\"TimesNewRoman\">L on </font><font face=\"TimesNewRoman\">thick blood smears.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">3. Evidence of a personally signed and dated informed consent document indicating that </font><font face=\"TimesNewRoman\">the subject (or a legally acceptable representative if a subject is <18 years of age) has </font><font face=\"TimesNewRoman\">been informed of all pertinent aspects of the study and that all questions by the </font><font face=\"TimesNewRoman\">subject have been sufficiently answered. Assent will be obtained from subjects <18 </font><font face=\"TimesNewRoman\">years of age.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">4. Subjects who are willing and able to comply with scheduled visits, treatment plan, </font><font face=\"TimesNewRoman\">laboratory tests, and other study procedures.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">5. Subjects who agree to be supervised for treatment administration, and are available </font><font face=\"TimesNewRoman\">for all follow up visits as per protocol.</font></p>\n
      • principal_exclusion_criteria<p align=\"left\">\n <font face=\"TimesNewRoman\">Subjects presenting with any of the following will not be randomized in the study:</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">1. Age <16 years old or >35 years old.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">2. Multiple gestations (more than one fetus) as per the ultrasound results at screening.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">3. Clinical symptoms of malaria.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">4. Hemoglobin <8 g/dL (measured at baseline).</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">5. Any condition requiring hospitalization or evidence of severe concomitant infection</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">at time of presentation.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">6. Use of antimalarial drugs in previous 4 weeks.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">7. History of convulsions, hypertension, diabetes or any other chronic illness that may</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">adversely affect fetal growth and viability.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">8. Inability to tolerate oral treatment in tablet form.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">9. Known allergy to the study drugs (AZ, CQ, and SP) or to any macrolides or</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">sulphonamides.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">10. Present history of smoking or alcohol or drug abuse since becoming pregnant.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">11. Participation in other studies within 30 days before the current study begins and/or</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">during study participation.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">12. Inability to comprehend and/or unwillingness to follow the study protocol.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\">13. Concurrent participation in another investigational study.</font></p>\n<p>\n <font face=\"TimesNewRoman\">14. Previously randomized in this study.</font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">15. Requirement to use medication during the study that might interfere with the</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">evaluation of the study drug of AZ or CQ or is contra-indicated during pregnancy per</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">package inserts.</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">16. Severe acute or chronic medical or psychiatric condition or laboratory abnormality</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">that may increase the risk associated with study participation or investigational</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">product administration or may interfere with the interpretation of study results and, in</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">the judgment of the investigator, would make the subject inappropriate for entry into</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">this study. Examples would include but not limited to:</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">a. Symptomatic HIV infection, including physical findings that suggest</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">immunocompromised status (eg, oral candidiasis);</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">b. Neurological conditions which may predispose to complications during</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">pregnancy, including seizure disorders;</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">c. Severe psychosis or major disorder that may interfere with the conduct of the</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">study or adherence to study medication;</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">d. Known, clinically significant pre-existing renal or hepatic disease.</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">17. Evidence of current obstetric complications that may adversely impact the pregnancy</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">and/or fetal outcomes, including presence of congenital anomalies, placenta previa or</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">abruption.</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">18. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.</font></font></p>\n<p align=\"left\">\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">19. Known family history of prolonged QT syndrome, serious ventricular arrhythmia, or</font></font></p>\n<p>\n <font face=\"TimesNewRoman\"><font face=\"TimesNewRoman\">sudden cardiac death.</font></font></p>\n<p>\n  </p>\n
      • primary_end_points<p align=\"left\">\n <font face=\"TimesNewRoman\">Primary Efficacy Endpoint</font></p>\n<p align=\"left\">\n <font face=\"Symbol\" lang=\"ZH-TW\">ï‚· </font><font face=\"TimesNewRoman\"><font face=\"Times New Roman\">Parasitological response (PCR corrected) at Day 28 post first dose of study</font></font></p>\n<p>\n <font face=\"TimesNewRoman\">medication.</font></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n UoN/Siaya District Hospital based clinical trial team and key roles</p>\n<p>\n  </p>\n<p>\n  </p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:540px;\" width=\"540\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n <strong>Study Team Members</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n <strong>   Designation</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Dr. Joshua Kimani</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Principal Investigator</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Prof. Benson Estambale</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Co- Principal Investigator</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Dr. Omoto Jackton</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Co- Principal Investigator</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>SITE CO-ORDINATOR</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Jacqueleen Wanjiru</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Site Coordinator</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>SUB INVESTIGATORS</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Dr. Annette Metho</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Medical Officer</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Dr. Jeremy Omondi</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Consultant Pediatrician</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Dr. Joan Muyoki Ngichabe</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Medical Officer </p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>CLINICAL TEAM</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Benard Wasonga</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Nurse</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Fredrick Oduor Ogutu</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Nurse</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Michael Otieno Abonyo</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Clinical Officer</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Sharon Chebet</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Nurse</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Maurice Wanga</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Nurse</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Jacktone Ogutu Okich</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Clinical Officer</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Linah Oule</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Nurse</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>LABORATORY TEAM</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n George Githongo</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Laboratory Manager</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Benson Odhiambo</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n James Kariuki Ndwiga</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Laboratory Assistant</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Olewe Perez Kola</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Vivian A Owino</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Microscopist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Daniel  Muyale</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Microscopist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>PHARMACY</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Dr. Geoffrey Mwai</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Pharmacist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Dr. Eunice Fwaya</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Pharmacist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Jeremiah Muriuki</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Pharmaceutical  Technologist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>SOCIO – WORK TEAM</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Bilhah M Wanjiru</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Social Scientist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Regina Akoth</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Social Scientist</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>PMTCT-VCT COUNSELLLORS</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Pamela Valerie Adhiambo</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Counselor</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>ULTRASONOGRAPHER</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Cheptoo Eglah</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Ultrasonographer</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n  Shadrack Ayieko</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Ultrasonographer</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n <p>\n <strong>SUPPORT STAFF</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Bernard P Akombi</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Driver</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Emily Awour Aloo</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Office Assistant</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Anne Adhiambo</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Office Assistant</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Magdalene Kamau</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Office Assistant</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n <p>\n Simon Dzombo</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n <p>\n Driver</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n No Malaria in the USA</p>\n
      • other_details_regulatory_notapproved<p>\n Non, all Regulatory Authorities approved the study.</p>\n
      • other_details_regulatory_approved<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width: 123px\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width: 177px\">\n <p>\n <strong>Name of Regulatory Body</strong></p>\n </td>\n <td style=\"width: 69px\">\n <p>\n <strong>Number of sites</strong></p>\n </td>\n <td style=\"width: 167px\">\n <p>\n <strong>Date of approval</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n <p>\n Benin</p>\n </td>\n <td style=\"width: 177px\">\n <p>\n MoH Department of Training in Health (Ministère de la Santé Direction de la Recherche en Santé)</p>\n </td>\n <td style=\"width: 69px\">\n <p>\n 1</p>\n </td>\n <td style=\"width: 167px\">\n <p>\n 23 Dec 2010</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n <p>\n Malawi</p>\n </td>\n <td style=\"width: 177px\">\n <p>\n Pharmacy Medicines and Poisons Board</p>\n </td>\n <td style=\"width: 69px\">\n <p>\n 1</p>\n </td>\n <td style=\"width: 167px\">\n <p>\n 20 Sept 2011</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n <p>\n Uganda</p>\n </td>\n <td style=\"width: 177px\">\n <p>\n National Drug Authority</p>\n </td>\n <td style=\"width: 69px\">\n <p>\n 1</p>\n </td>\n <td style=\"width: 167px\">\n <p>\n 16 March 2012</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n <p>\n Tanzania</p>\n </td>\n <td style=\"width: 177px\">\n <p>\n Tanzania Food and Drug Authority</p>\n </td>\n <td style=\"width: 69px\">\n <p>\n 2</p>\n </td>\n <td style=\"width: 167px\">\n <p>\n 14 April 2011</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration07 March 2011 to 30 April 2013
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaUniversity of Nairobi Institute of Tropical and Infectious Diseases Siaya District Hospital
      • single_site_physical_address Siaya District Hospital ,P.O. Box 144-40600, Siaya, Kenya
      • single_site_contact_personDr Joshua Kimani
      • single_site_telephone+254 733 719711
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listUganda, Malawi, Tanzania, Benin
      • data_monitoring_committeeYes
      • total_enrolment_per_site80
      • total_participants_worldwide166
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJoshua
      • investigator1_middle_name
      • investigator1_family_nameKimani
      • investigator1_qualificationMB Ch. B, MPH (Epidemiology)
      • investigator1_professional_addressUniversity of Nairobi Institute of Tropical and Infectious Diseases(UNITID), College of Health Sciences, University of Nairobi, Nairobi, Kenya
      • investigator1_telephone+254 20 234 1108
      • investigator1_emailjkimani@csrtkenya.org
      • organisations_transferred_Yes
      • number_participants80
      • notification
      • approval_date25-09-2013
      • submitted1
      • deleted0
      • deleted_date2014-02-20 18:15:20
      • deactivated0
      • date_submitted21-02-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-07-07 15:05:38
      • created2013-09-25 18:03:29
      • total_sites(null)
      • ecitizen_invoice(null)
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id150
        • application_id216
        • given_nameJoshua
        • middle_name
        • family_nameKimani
        • qualificationMB ChB, MPH( Epidemiology)
        • professional_addressUniversity of Nairobi Institute of Tropical and Infectious Diseases (UNITID), College of Health Sciences ,Nairobi, Kenya
        • telephone0733719711
        • emailjkimani@csrtkenya.org
        • investigator_roleprincipal
        • created2013-09-26 12:04:23
        • modified2014-02-21 15:00:36
    • SiteDetail(array)
      • 0(array)
        • id189
        • application_id216
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-09-26 12:04:23
        • modified2014-02-21 15:00:36
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id118
        • application_id216
        • sponsorPfizer
        • sponsor_type(null)
        • contact_personRicardo Rojo Cella
        • address445 Eastern Point Rd, Groton CT USA, 06340
        • telephone_number8604410547
        • fax_number
        • cell_number 8609106576
        • email_addressRicardo.rojo@pfizer.com
        • created2013-09-26 12:04:23
        • modified2014-02-21 15:00:36
  • 1(array)
    • Application(array)
      • id1422
      • user_id263
      • trial_status_id1
      • abstract_of_study<p align=\"left\">\n This will be a phase III, hospital-based, parallel, two-arm, individually-randomized, double-blind, active controlled, international, multicentre, non-inferiority trial. Participating women will be randomized to receive either intravenous HSC or oxytocin as the ‘first-line’ uterotonic for PPH treatment.</p>\n<p align=\"left\">\n The trial will be conducted across 20 tertiary level hospitals within the WHO “CHAMPION” Trial Network in Argentina, Kenya, India, Nigeria, Uganda, South Africa, and United Kingdom.</p>\n<p align=\"left\">\n Care providers will inform potentially eligible pregnant women about the trial during their antenatal care visits to the hospital. If a woman is seen for the first time during her admission to the hospital for childbirth, she will be provided information about the trial then. Women will be approached for participation in the trial if she is in early labour (<6cm cervical dilatation), her vital signs are normal, and she is not distressed at the moment of giving consent. Informed consent will be obtained from the woman before any trial-related procedures are carried out.</p>\n<p align=\"left\">\n Women having a vaginal birth who have been consented in early labour will receive an intramuscular (IM) prophylactic 100 µg dose of HSC for PPH prevention. Following the birth of the baby, a calibrated drape will be placed under the woman’s buttocks to measure blood loss following birth. Should atonic PPH based on a clinical diagnosis or blood loss estimation of 500 ml or more occur, the woman will be randomized to receive a saline intravenous (IV) infusion of HSC 100 µg or oxytocin 5 IU over 5 minutes. Following this treatment, women in the oxytocin arm (active control) will receive an additional 20 IU at a lower saline infusion rate over 4 hours in line with standard clinical practice, while women in HSC arm will receive an equivalent amount of saline infusion but with no additional uterotonic for the same period. Upon randomization, a new drape will be placed under the woman’s buttocks to measure further blood loss for 90 minutes. </p>\n<p align=\"left\">\n The investigational medicinal product (IMP) will be administered immediately following randomization of trial participants. Once the IMP has been administered to the woman as described above, the clinical staff will continue further PPH management in accordance with existing hospital PPH management protocol and WHO guidelines.</p>\n<p align=\"left\">\n All women will be followed up for 24 hours after randomization or until hospital discharge, whichever is soonest.</p>\n<p>\n The trial will be implemented with an internal safety sub-study. The first interim analysis will be conducted for an independent Data Safety Monitoring Committee (DSMC) to assess comparative safety of HSC versus oxytocin once the first 250 participants have been enrolled into the trial. </p>\n
      • study_title<p align=\"left\">\n <strong>Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial</strong></p>\n
      • laymans_summary<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Title: A Phase III Trial Comparing HSC and Oxytocin for Postpartum Hemorrhage Prevention</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Objective: This international, multicenter trial aims to compare the effectiveness and safety of intravenous HSC (an investigational uterotonic) with oxytocin (the current standard) for preventing postpartum hemorrhage (PPH).</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Study Design:</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Type: Hospital-based, parallel, two-arm, individually-randomized, double-blind, active controlled.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Participants: Pregnant women at 20 tertiary level hospitals across Argentina, Kenya, India, Nigeria, Uganda, South Africa, and the United Kingdom.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Eligibility: Women in early labor with normal vital signs and no distress.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Randomization: Participants will receive either HSC or oxytocin as the first-line uterotonic.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Treatment Administration: Women having a vaginal birth will receive an intramuscular prophylactic dose of HSC. If atonic PPH occurs (500 ml blood loss or more), they will be randomized to receive either HSC or oxytocin via intravenous infusion.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Follow-up: All women will be monitored for 24 hours after randomization or until hospital discharge.</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Safety Sub-Study:</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n An internal safety sub-study will assess the comparative safety of HSC versus oxytocin.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n The first interim analysis will occur after enrolling the first 250 participants.</p>\n<p lang=\"en-ZA\" style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n  </p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n This trial aims to improve PPH management and enhance maternal health outcomes.</p>\n<p style=\"padding: 0px; margin: 12px 0px 0px; word-break: break-word; font-size: 16px; line-height: var(--cib-type-body2-line-height); font-variation-settings: var(--cib-type-body2-font-variation-settings); color: rgb(17, 17, 17); font-family: -apple-system, Roboto, SegoeUI, "Segoe UI", "Helvetica Neue", Helvetica, "Microsoft YaHei", "Meiryo UI", Meiryo, "Arial Unicode MS", sans-serif; background-color: rgb(247, 247, 247);\">\n  </p>\n
      • short_titleWHO A66045
      • protocol_noECCT/24/08/04
      • version_no3.0
      • date_of_protocol03-09-2023
      • study_drugHeat-stable carbetocin (HSC)
      • disease_conditionpostpartum haemorrhage
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameHeat-stable carbetocin (HSC)
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameoxytocin
      • comparator_registeredyes
      • comparator_countriesMost countries including Kenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDanielle Erasmus
      • declaration_date113-08-2024
      • declaration_principal_investigatorProf Zahida Qureshi
      • declaration_date213-08-2024
      • placebo_presentNo
      • study_objectives<p>\n The main aim of this trial is to generate evidence on the efficacy and safety of HSC compared to oxytocin when used as ‘first-line’ uterotonic for PPH treatment.</p>\n<p>\n The <strong>primary objective</strong> of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization.</p>\n<p>\n There are two hypotheses for the primary objective (one non-inferiority and one superiority hypotheses):</p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:601px;height:68px;\">\n <ol>\n <li>\n Intravenous (IV) HSC is non-inferior to IV oxytocin in terms of the proportion of women with PPH experiencing additional blood loss of 500 ml or more within a non-inferiority margin of 4% risk difference scale (primary hypothesis).</li>\n <li>\n Intravenous (IV) HSC is superior to IV oxytocin in terms of the proportion of women with PPH experiencing additional blood loss of 500 ml or more (secondary hypothesis). </li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n The <strong>secondary objectives</strong> are to (i) evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; and (ii) evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Trial participants will be women who receive HSC for PPH prophylaxis and are diagnosed with PPH presumed to be due to uterine atony after a vaginal birth.</p>\n<p>\n To be eligible for inclusion into this trial, the women must fulfil <strong><u>all</u></strong> the following criteria:</p>\n<ul>\n <li>\n had a singleton pregnancy</li>\n <li>\n had a vaginal birth</li>\n <li>\n receive HSC (IM) for PPH prophylaxis</li>\n</ul>\n<ul>\n <li align=\"left\">\n have an indication to receive uterotonics for the treatment of PPH presumed due to uterine atony (clinically diagnosed, or measured vaginal blood loss of 500 ml or more in the first 60 minutes postpartum) and where known coagulopathy and retained placenta has been excluded as the cause of bleeding)</li>\n</ul>\n<ul>\n <li>\n provide written informed consent before any trial-related procedures are carried out</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n Women are not eligible for this trial if they fulfill <strong><u>any</u></strong> of the following exclusion criteria:</p>\n<ul>\n <li align=\"left\">\n known history of allergy to oxytocin or HSC or any of their excipients.</li>\n <li align=\"left\">\n known serious coagulopathy, epilepsy, hepatic, renal, or cardiovascular disease.</li>\n <li align=\"left\">\n known intrauterine fetal death.</li>\n <li align=\"left\">\n birth that is considered an abortion according to local gestational age limit.</li>\n <li align=\"left\">\n have other clinically significant condition(s) that, in the opinion of the investigator could represent increased risk for the participation of the woman or interfere with the objectives of the study.</li>\n <li align=\"left\">\n a manual removal of placenta.</li>\n <li align=\"left\">\n a placenta in situ that has not been expelled or removed.</li>\n <li align=\"left\">\n known administration of any uterotonic for PPH treatment (e.g. prostaglandins, oxytocin, ergometrine) following PPH prophylaxis.</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<h3>\n Primary end-points</h3>\n<p>\n The primary end-point is the proportion of women with additional vaginal blood loss of ≥ 500 ml at 90 minutes following randomization.</p>\n<p>\n <strong>Key Secondary end-points</strong></p>\n<ul>\n <li>\n The proportion of women with additional blood loss of ≥1000 ml at 90 minutes following randomization</li>\n <li>\n The proportion of women receiving additional uterotonics at 90 minutes following randomization</li>\n <li>\n The proportion of women with additional blood loss of ≥ 500 ml or receiving additional uterotonic(s) at 90 minutes following randomization</li>\n <li>\n The proportion of women having surgical procedures related to PPH (e.g. laparotomy for compressive sutures, artery ligation or hysterectomy, or uterine balloon tamponade) as at 24 hours following randomization.</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment up to 24 hours.  </li>\n</ul>\n<p>\n <strong>Other secondary end-points</strong></p>\n<ul>\n <li>\n Amount of blood loss in ml at 90 minutes following randomization</li>\n <li>\n The proportion of women receiving additional uterotonics as at 24 hours following randomization</li>\n <li>\n The proportion of women receiving blood transfusion products up to 24 hours following randomization</li>\n <li>\n The proportion of women admitted to intensive care unit as at 24 hours following randomization</li>\n <li>\n The proportion of maternal deaths</li>\n <li>\n The proportion of women with clinically defined coagulopathy as documented in medical records as at 24 hours following randomization</li>\n <li>\n The proportion of women breastfeeding as at 24 hours following randomization</li>\n</ul>\n<ul>\n <li>\n The proportion of women hypovolemic shock up to 24 hours following randomization</li>\n <li>\n The proportion and severity of adverse or serious adverse events up to 24 hours following randomization</li>\n <li>\n The proportion of women with composite outcome of maternal death or severe morbidity as at 24 hours following randomization into trial</li>\n</ul>\n<ul>\n <li>\n The proportion of women with any haemodynamic change requiring therapeutic intervention during the first 10 minutes of administering treatment infusion</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment in the first 10 minutes after initiating treatment infusion</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which results in cardiac arrest during the first 24 hours following randomization</li>\n</ul>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n 1. Qureshi Zahida, MBChB, Mmed Ob/Gyn</div>\n<div>\n Associate Professor of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi, Department of Obstetrics and Gynaecology</div>\n<div>\n P.O Box 19676-00202 KNH, Nairobi Kenya 0733605410</div>\n<div>\n zahida@qureshi.co.ke</div>\n<div>\n Principal Investigator: Responsible for the development and overall project oversight, science and overseeing all implementing team members in Kenya</div>\n<div>\n  </div>\n<div>\n 2. Osoti Alfred. MBChB, Mmed (Ob/Gyn), MPH, PHD</div>\n<div>\n Associate Professor, Department of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi</div>\n<div>\n P.O Box 2343 00202 KNH Nairobi 0733886664</div>\n<div>\n alfredos@uw.edu</div>\n<div>\n Co-Investigator: Responsible for Human Resource, monitoring and evaluation and quality control during data collection period</div>\n<div>\n  </div>\n<div>\n 3. Gwako George. MBChB, Mmed (Ob/Gyn), PHD</div>\n<div>\n Lecturer, Department of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi</div>\n<div>\n P.O Box 4848-00200 Nairobi 0722992268</div>\n<div>\n gngwako@gmail.com</div>\n<div>\n Co-Investigator: Responsible for guiding study design, implementation and analysis</div>\n<div>\n  </div>\n<div>\n We are ideally suited to work with the Ministry of Health, County level 5 Hospitals. We have identified 3 sites that will serve as potential sites for this trial. These are;</div>\n<div>\n  </div>\n<div>\n Machakos County Referral Hospital – Lead Obstetrician Gynecologist Dr. Alice Isika</div>\n<div>\n Kiambu Level 5 Hospital – Lead Obstetrician Gynecologist Dr. Mary Maina</div>\n<div>\n Pumwani maternity Hospital – Lead Obstetrician Gynecologist Dr. Mandi Sura</div>\n<p>\n <strong>Machakos Level 5 Hospital</strong> is a public referral hospital located in Machakos County. It handles over 500 deliveries per month. The hospital offers a variety of services for outpatients (General Care, Dental Services, Pharmacy Services, Laboratory Services, Imaging Services, HIV/AIDS Prevention Treatment and Care, Maternal and Child Health, Eye Services, Nutrition Services) as well as inpatients (Medical ward/Surgical ward, Maternity Ward, Post Natal Ward, New Born Unit, Pediatric Ward, Operating Theatre, Inpatient gynaecology consultation, Physiotherapy). The hospital provides ANC to approximately 200 women each month. It has a 507-bed capacity with 57 newborn cots. There are 2 consultant obstetricians/gynaecologists, and 4 Medical Officers. It has an average of 350 deliveries in a month. The hospital has established referral networks with emergency transport availability.</p>\n<p>\n During the trial, skilled and adequately GCP trained individuals will be involved in the trial management. When the woman attends the delivery suite, a skilled health personnel in charge of caring women in labor at the hospital will provide sufficient information about the trial and, will request consent from the participant. Following birth of the baby, screening of the consented participants will be undertaken to ensure eligibility by a skilled and trained, member of research team. Eligibly participants will be randomized and  the member of the research team will conduct ongoing data collection safely and effectively.</p>\n<div>\n <strong>Kiambu Level 5 Hospital </strong>is a public health facility situated in Kiambu County. It serves a large population both urban and rural. The hospital serves as the referral center for catchment areas from nearby sub counties.. It has 45 beds dedicated to the maternity unit. The hospital provides Antenatal services to approximately 260 women per month. It has 2 Obstetrician gynaecologists, 3 Medical officers and 27 midwives. It handles approximately 700 deliveries per month. The preterm birth (<34 weeks) rate Is 7%. The preterm mortality rate is 45%. About 34% pregnant mothers are registered to ANC before 12 weeks of gestation.</div>\n<div>\n Available services include ultrasonography, tocolytic drugs, antenatal corticosteroids, caesarean sections and instrumental deliveries- Vacuum deliveries. It has a 46 bed capacity maternity ward with 22 midwives, 4 medical officers and 5 Obstetrician/Gynaecologists. There is piped oxygen and a 2 bed adult ICU, where a 3rd bed is created for Obstetric patients. The new born unit is a 50 bed capacity with 11 nurses and 4 paeditricians. There is no NICU. Basic resuscitation services are available including incubators, radiant heaters and piped oxygen. CPAP is available, however exogenous surfactant is not available.</div>\n<div>\n  </div>\n<div>\n <div>\n <strong>Pumwani Maternity Hospital </strong>is the largest maternity hospital situated in Nairobi County. The facility is managed by the County Government of Nairobi. It serves as the major referral centre for the county and beyond. The hospital provides comprehensive emergency obstetric and newborn care and has ultrasound services.</div>\n <div>\n The facility has 354 obstetrics bed capacity, 144 baby cots and 2 operating theatres. There are 4 Obstetrician gynaecologists, 4 Medical Officers and 25 Midwives. Average number of deliveries per month is 1000 with approximately 70-100 per day. The facility has well equipped laboratory and functional blood transfusion services.</div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Sites that participated in the CHAMPION study and are part of the WHO CHAMPION Trial network will participate in this study. If licensed, HSC would have most benefit in settings where temperature control uterotonics cannot be guaranteed. Switzerland would not meet these criteria. That said, as a representative of a HIC we have selected the UK to ensure the diversity of settings. The trial site in the UK previously participated in the CHAMPION Trial and has local expertise in PPH treatment trials.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n South Africa: SAHPRA approval dated 22 Jan 2024- 2 Sites</p>\n<p>\n  </p>\n<p>\n UK – MHRA approval date 05Mar2024 – 1 site</p>\n<p>\n  </p>\n<p>\n ARG – ANMAT approval date 30 May 2024 – 2 sites</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration54 months according to the following schedules: 12 months for trial preparation; 30 months for trial enrolment; and 12 months for final analysis, trial publication and dissemination of results.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyActive controlled, non-inferiority trial
      • design_controlled_comparatorOxytocin
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites3
      • multi_country_listArgentina, India, Kenya, Nigeria, South Africa, Uganda, and United Kingdom
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMachakos county hospital: we estimate around 393 women could be randomized across 30 months. \nPumwani maternity hospital: we estimate around 301 women could be randomized across 30 months\nKiambu level five hospital: we estimate around 376 women could be randomized across 30 months.
      • total_participants_worldwide6200
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_nameQureshi
      • investigator1_qualificationMBBS, Mmed, Ob/Gyn
      • investigator1_professional_addressPO Box 19676-00202 Kenyatta National Hospital Nairobi Kenya
      • investigator1_telephone+254 733 605 410
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_Yes
      • number_participants1000
      • notification
      • approval_date06-02-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-08-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted16-08-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer queries have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2026-03-06 20:46:14
      • created2024-06-18 16:21:02
      • total_sites(null)
      • ecitizen_invoice(null)
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1079
        • application_id1422
        • given_nameZahida
        • middle_name
        • family_nameQureshi
        • qualificationMBBS, Mmed, Ob/Gyn
        • professional_addressPO Box 19676-00202 Kenyatta National Hospital Nairobi Kenya
        • telephone+254 733 605 410
        • emailzahida@qureshi.co.ke
        • investigator_roleprincipal
        • created2024-06-18 16:34:25
        • modified2025-07-03 15:09:44
    • SiteDetail(array)
      • 0(array)
        • id1725
        • application_id1422
        • county_id16
        • site_name Machakos county hospital
        • physical_addressP.O Box 19-90100 Machakos
        • contact_details+254721404445
        • contact_personDr. Alice Isika
        • site_capacity(null)
        • misc(null)
        • created2024-06-18 16:34:25
        • modified2025-07-03 15:09:44
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 1(array)
        • id1726
        • application_id1422
        • county_id47
        • site_namePumwani maternity hospital
        • physical_addressP. O Box 42849-00100 Nairobi
        • contact_details+254722775150
        • contact_personDr. Mandeep Sura
        • site_capacity(null)
        • misc(null)
        • created2024-06-19 16:07:14
        • modified2025-07-03 15:09:44
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1727
        • application_id1422
        • county_id22
        • site_nameKiambu level 5 hospital
        • physical_addressP.O Box 39-00900 Kiambu
        • contact_details +254722327304
        • contact_personDr. Mary Maina
        • site_capacity(null)
        • misc(null)
        • created2024-06-19 16:08:29
        • modified2025-07-03 15:09:44
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id755
        • application_id1422
        • sponsorWHO
        • sponsor_typeIndustry
        • contact_personMariana Widmer
        • addressAvenue Appia 20 1211 Geneva 27 Switzerland
        • telephone_number+41227914323
        • fax_number
        • cell_number+41227914323
        • email_addresswidmerm@who.int
        • created2024-06-18 16:34:25
        • modified2025-07-03 15:09:44
  • 2(array)
    • Application(array)
      • id1591
      • user_id127
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong>Protocol Title:</strong> A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis</p>\n<p>\n <strong>Short Title:</strong> MK-8527 as HIV-1 PrEP</p>\n<p>\n <strong>Objectives</strong>: The following primary objectives will be evaluated in cisgender men, TGW, TGM, and GNB people ≥16 years of age who have sex with partners assigned male sex at birth and are at greater likelihood of HIV-1 exposure.</p>\n<ul>\n <li>\n To evaluate the efficacy of MK-8527 qm compared to FTC/TDF ad for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections.</li>\n <li>\n To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.</li>\n</ul>\n<p>\n <strong>Study Design</strong><strong><em>:</em></strong> This is a randomized, active-controlled, parallel-group, multisite, double-blind, double dummy study to evaluate the efficacy and safety of MK-8527 oral qm as PrEP in cisgender men, TGW, TGM, and GNB people ≥16 years of age who have sex with partners assigned male sex at birth and are at greater likelihood of HIV-1 exposure. The active comparator in this study will be FTC/TDF qd. Approximately 4,390 participants will be randomized in a 1:1 ratio to 1 of 2 intervention groups, the MK-8527 qm group or the FTC/TDF qd group.</p>\n<p>\n <strong>Estimated Duration of Study: </strong>The Sponsor estimates that the study will require approximately 33 months from the time the first participant (or their legally acceptable representative) provides documented informed consent until the last participant’s last study-related contact. Because this is an endpoint-driven study, 33 months is an estimate of study duration.</p>\n<p>\n <strong>Duration of Participation: </strong>Because this is an endpoint-driven study, participation times will vary depending on when the participant is enrolled and time for HIV-1 infection case accrual. Participants will be enrolled over an approximately 12-month period with study intervention administered for up to 30 months, based on estimated accrual of primary endpoint cases. Participants who discontinue study intervention, become pregnant, or decide to breast/chestfeed will be followed as described in the protocol.</p>\n<p>\n <strong>Analysis</strong><strong><em>:</em></strong> The primary efficacy objective will be assessed based on the incidence rate of adjudicated HIV-1 infections while the safety and tolerability objective will be assessed by clinical review of all relevant parameters including AEs, laboratory test values, and vital signs.</p>\n<p>\n  </p>\n
      • study_title<p align=\"left\">\n A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis</p>\n
      • laymans_summary<p>\n This study is testing a new medication called <strong>MK-8527</strong>, taken as a pill <strong>once a month</strong>, to see if it is safe and effective in preventing HIV infection among people at higher risk of getting HIV.</p>\n<p>\n The study will include <strong>people aged 16 years and older</strong> who were born male and have sex with other people who were also born male. This group includes <strong>men whose gender matches the sex they were born with (cisgender men)</strong>, <strong>transgender women (people who were born male but identify as women)</strong>, <strong>transgender men (people who were born female but identify as men)</strong>, and <strong>gender-diverse individuals who do not identify strictly as male or female</strong>.</p>\n<p>\n The research compares <strong>MK-8527</strong> to the standard daily HIV prevention pill called <strong>FTC/TDF</strong>. Participants will be randomly placed into two groups.</p>\n<p align=\"left\" style=\"margin-left:36pt;\">\n ·       <strong>One group takes the MK-8527 pill once a month and a daily pill with no medicine (placebo).</strong></p>\n<p align=\"left\" style=\"margin-left:36pt;\">\n ·       <strong>The other group takes FTC/TDF every day and a monthly placebo pill.</strong></p>\n<p>\n Neither the participants nor the researchers know which treatment each person is receiving. This is called a <strong>double-blind study</strong>, and it helps ensure fair and accurate results.</p>\n<p>\n The study will take place at multiple locations with around <strong>4,390 participants</strong>. Each participant may be involved for up to <strong>30 months</strong>, with regular clinic visits for HIV testing and safety checks. If someone becomes pregnant or chooses to breastfeed, they may be switched to <strong>FTC/TDF</strong> in a way where both the participant and the study team know what medicine is being given.</p>\n<p>\n Mainly the study aims to<strong> find out if MK-8527 works as well as or better than the daily FTC/TDF pill in preventing HIV and also to check if MK-8527 causes any side effects or health problems.</strong></p>\n<p>\n Researchers hope that this new once-a-month pill will provide a more convenient HIV prevention option and encourage more people to stay protected.</p>\n
      • short_titleMK-8527-011 Study
      • protocol_noECCT/25/11/06
      • version_no0.0
      • date_of_protocol28-04-2025
      • study_drugMK-8527
      • disease_conditionHIV 1
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameMK8527 (Investigational)
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameFTC/TDF(Emtricitabine/Tenofovir Disoproxil Fumarates)
      • comparator_registeredYES
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmaricianah@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Maricianah Onono
      • declaration_date127-11-2025
      • declaration_principal_investigatorDr. Maricianah Onono
      • declaration_date227-11-2025
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary</strong> <strong>Objectives</strong></p>\n<p style=\"margin-left:5.3500pt;\">\n 1.To evaluate the efficacy of MK-8527 qm compared to FTC/TDF ad for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections.</p>\n<p style=\"margin-left:5.3500pt;\">\n <strong>Hypothesis (H1)</strong>: MK-8527 qm is noninferior to FTC/TDF qd with respect to the hazard ratio for HIV-1 infection.</p>\n<p>\n  </p>\n<p>\n <strong>Hypothesis</strong> <strong>(H2)</strong>: MK-8527 qm is superior to FTC/TDF qd with respect to the hazard ratio for HIV-1 infection.</p>\n<p>\n 2.To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.</p>\n
      • principal_inclusion_criteria<h2>\n Inclusion</h2>\n<p>\n The site will consider a participant eligible for inclusion in the study if the individual meets all of the following criteria:</p>\n<p>\n  </p>\n<p>\n <strong>Type of Participant and Disease Characteristics</strong></p>\n<p style=\"margin-left:17.8500pt;\">\n 1. Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening.</p>\n<p style=\"margin-left:17.8500pt;\">\n <em>Note: Any positive HIV test during the Screening Period will exclude the participant from the study regardless of a negative confirmatory test. Additional testing to confirm suspected HIV infection during screening will be performed in accordance with local guidelines. If HIV infection is confirmed, participants will be referred for appropriate care, as necessary</em>.</p>\n<p style=\"margin-left:17.8500pt;\">\n 2. Is a cisgender man, TGW (assigned male sex at birth), TGM (assigned female sex at birth), or GNB person.</p>\n<p style=\"margin-left:17.8500pt;\">\n 3. Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following:</p>\n<p style=\"margin-left:28.4000pt;\">\n · Receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use)</p>\n<p style=\"margin-left:28.4000pt;\">\n · Rectal or urethral gonorrhoea or chlamydia or incident syphilis in the 6 months prior to screening</p>\n<p style=\"margin-left:28.4000pt;\">\n · Any self-reported stimulant drug use with sex in the 3 months prior to screening</p>\n<p>\n <strong>Demographics</strong></p>\n<p style=\"margin-left:17.8500pt;\">\n 4. Is ≥16 years of age at the time of providing the informed consent or assent, as applicable.</p>\n<p style=\"margin-left:17.8500pt;\">\n <em>Note: Enrolment for 16- to 17-year-old participants may begin only after completion and review of the initial safety review results by the eDMC (refer to the section on statistical considerations).</em></p>\n<p style=\"margin-left:17.8500pt;\">\n 5. Weighs ≥35 kg at enrolment.</p>\n<p>\n <strong>Assigned Male Sex at Birth</strong></p>\n<p>\n Note: There are no contraceptive requirements for participants assigned male sex at birth.</p>\n<p>\n <strong>Assigned Female Sex at Birth</strong></p>\n<p style=\"margin-left:17.8500pt;\">\n 6. A participant assigned female sex at birth is eligible to participate if not breast/chest feeding.</p>\n<p style=\"margin-left:17.8500pt;\">\n 7. A participant of child bearing potential (POCBP) is eligible to participate if not pregnant and if a negative highly sensitive pregnancy test (urine or serum), as required by local regulations, has been obtained within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.</p>\n<p style=\"margin-left:17.8500pt;\">\n 8. A POCBP is eligible to participate if they use an acceptable contraceptive method or if they adhere to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 56 days after the last dose of blinded monthly study intervention.</p>\n<p style=\"margin-left:17.8500pt;\">\n - Note: The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recent initiation) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the local contraception requirements for any of the study interventions are more stringent than the requirements above, the local requirements are to be followed. Medical history, menstrual history, and recent sexual activity should be reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.</p>\n<p>\n <strong>Informed Consent</strong></p>\n<p style=\"margin-left:17.8500pt;\">\n 9. The participant (or participant's legally acceptable representative) has provided documented informed consent and the participant has provided documented assent, when applicable, for the study.</p>\n<p>\n <strong>Additional Categories</strong></p>\n<p style=\"margin-left:17.8500pt;\">\n 10. Has no plans to travel or relocate away from the site that would interfere with attending monthly on-site visits for the duration of the study.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<h3>\n Exclusion Criteria</h3>\n<h3>\n  </h3>\n<p>\n <span style=\"font-size: 12px;\">The site will exclude and individual from the study if they meet any of the following criteria:</span></p>\n<p>\n  </p>\n<p>\n <strong>Medical Conditions</strong></p>\n<p style=\"margin-left:18.0000pt;\">\n 1. Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator.</p>\n<p style=\"margin-left:18.0000pt;\">\n 2. Has evidence of acute or chronic hepatitis B infection (HBsAg positive).</p>\n<p style=\"margin-left:18.0000pt;\">\n <em>Note: Participants with isolated HBcAb positivity (HBsAg and HBsAb negative) will be excluded if HBV DNA is positive.</em></p>\n<p style=\"margin-left:18.0000pt;\">\n <em>Note: Participants who do not demonstrate immunity to HBV will be offered HBV vaccination.</em></p>\n<p style=\"margin-left:18.0000pt;\">\n 3. Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers.</p>\n<p style=\"margin-left:18.0000pt;\">\n 4. Has a history or current evidence of any condition (e.g., active tuberculosis infection or hepatic cirrhosis), therapy, laboratory abnormality or other circumstance (including substance or alcohol use disorder) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to enrol.</p>\n<p>\n <strong>Prior/Concomitant Therapy</strong></p>\n<p style=\"margin-left:18.0000pt;\">\n 5. Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time (past or current use).</p>\n<p>\n <em>Note: Prior use of ISL (MK-8591) is permitted.</em></p>\n<p style=\"margin-left:18.0000pt;\">\n 6. Is currently receiving or is anticipated to require any prohibited therapies outlined in Section 6.5 from 30 days prior to Day 1 through the study duration (i.e., up to 56 ± 5 days following the last dose of blinded monthly study intervention).</p>\n<p style=\"margin-left:18.0000pt;\">\n <em>Note: Participants taking or starting tenofovir-based PrEP at screening may continue their regimen until 24 hours before the blinded monthly dose on Day 1.</em></p>\n<p style=\"margin-left:18.0000pt;\">\n 7. Has received an HIV vaccine at any time (i.e., through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1.</p>\n<p>\n <strong>Prior/Concurrent Clinical Study Experience</strong></p>\n<p style=\"margin-left:18.0000pt;\">\n 8. Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device within 30 days prior to Day 1 through the duration of the study.</p>\n<p style=\"margin-left:18.0000pt;\">\n <em>Note: Concurrent participation in observational or noninterventional studies or longitudinal follow-up from interventional studies may be permitted and should be discussed with the Sponsor before enrolment and through study duration.</em></p>\n<p>\n <strong>Diagnostic Assessments</strong></p>\n<p style=\"margin-left:18.0000pt;\">\n 9. Has exclusionary laboratory values within 45 days prior to Day 1 as listed below.</p>\n<p style=\"margin-left:18.0000pt;\">\n Note: A single repeat of a laboratory screening test will be allowed for test results that are unexpected, but the repeat test results must be available within the 45-day screening window.</p>\n<p style=\"margin-left:28.4000pt;\">\n · Absolute neutrophil count ≤750 cells/mm3</p>\n<p style=\"margin-left:28.4000pt;\">\n · Alkaline phosphatase >3 × upper limit of normal (ULN)</p>\n<p style=\"margin-left:28.4000pt;\">\n · Alanine aminotransferase (ALT) >3 × ULN</p>\n<p style=\"margin-left:28.4000pt;\">\n · Aspartate aminotransferase (AST) >3 × ULN</p>\n<p style=\"margin-left:28.4000pt;\">\n · Total bilirubin ≥2.5 × ULN</p>\n<p style=\"margin-left:28.4000pt;\">\n · estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2</p>\n<p style=\"margin-left:28.4000pt;\">\n · Haemoglobin <9.0 g/dL</p>\n<p style=\"margin-left:28.4000pt;\">\n · Platelet count <100,000/mm3</p>\n<p>\n <strong>Other Exclusions</strong></p>\n<p style=\"margin-left:18.0000pt;\">\n 10. Is expecting to donate eggs at any time during the study.</p>\n<p style=\"margin-left:18.0000pt;\">\n <em>Note: Investigators should provide appropriate guidance to participants assigned female sex at birth regarding egg donation after completion of the study intervention. It is recommended that all participants assigned female sex at birth refrain from egg donation for at least 56 days following their last dose of blinded monthly study intervention.</em></p>\n<p style=\"margin-left:18.0000pt;\">\n 11. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.</p>\n
      • primary_end_points<p>\n 1.Adjudicated HIV-1 infection</p>\n<p>\n 2.Adverse events</p>\n<p>\n 3.Adverse events leading to discontinuation of study intervention</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The sites have infrastructure thst includes adequate study space,laboratory equipment,experienced staff who have been involved in a nunber of phase 2 and 3 trials.</p>\n<p>\n The staff also have experience in contraceptive counselling and administration</p>\n
      • other_details_explanation<p>\n <span style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Kenya continues to face a significant HIV burden, particularly among women of reproductive age, who account for a large proportion of new infections. Conducting this trial in Kenya allows for the </span><span style=\"font-family: arial, sans-serif; font-variant-ligatures: no-contextual;\">addressing of a critical public health priority through an innovative intervention that aligns with national HIV prevention strategies and </span><span style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">for the evaluation of MK-8527, a once-monthly oral PrEP candidate, in a high-risk population where its impact could be most meaningful. The study will generate locally relevant data, support public health efforts, and leverage Kenya’s strong research infrastructure to address a critical unmet need in HIV prevention.</span></p>\n
      • other_details_regulatory_notapproved<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Kenya Medical Research Institute- Scientific Ethics Research Unit (SERU) </span></p>\n<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">27 Aug 2025</span></p>\n
      • other_details_regulatory_approved<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Name of Ethics Committee: University of the Witwatersrand Human Research Ethics Committee WHREC , South Africa</span></p>\n<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Date of approval: 25 Sep 2025</span></p>\n<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Number of Sites: 6 (South Africa)</span></p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration33 Months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorFTC/TDF
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states1
      • number_of_sites3
      • multi_country_listSouth Africa\n
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMinimum of 160 participants and maximum of 500 participants
      • total_participants_worldwide4390
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyAdolescents 16 and 17 years old
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Maricianah
      • investigator1_middle_name
      • investigator1_family_nameOnono
      • investigator1_qualificationMBChB, Msc, PhD, MMed
      • investigator1_professional_address19669-40123 kisumu
      • investigator1_telephone0732390992
      • investigator1_emailmaricianah@gmail.com
      • organisations_transferred_Yes
      • number_participants600
      • notification
      • approval_date05-03-2026
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-12-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted27-11-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2026-04-02 16:50:43
      • created2025-09-10 11:03:43
      • total_sites1
      • ecitizen_invoice390637
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1358
        • application_id1591
        • given_nameDr Maricianah
        • middle_name
        • family_nameOnono
        • qualificationMBChB, Msc, PhD, MMed
        • professional_address19669-40123 Kisumu
        • telephone0732390992
        • emailmaricianah@gmail.com
        • investigator_roleprincipal
        • created2025-09-10 11:29:28
        • modified2025-12-16 13:30:02
    • SiteDetail(array)
      • 0(array)
        • id1996
        • application_id1591
        • county_id42
        • site_nameNyanza Reproductive Health Society (NRHS), UNIM Research and Training Centre (URTC)
        • physical_addressLumumba SubCounty Hospital compound, off Ondiek Highway, Kisumu, Kenya
        • contact_details+254 57 2024065,PO BOX 1764-40100 , Kisumu
        • contact_personDr Maricianah Onono
        • site_capacity(null)
        • misc(null)
        • created2025-09-10 11:29:28
        • modified2025-12-16 13:30:02
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1999
        • application_id1591
        • county_id42
        • site_nameKenya Impact Research and Development Organization (K-IRDO)
        • physical_addressTuungane Hospital, Kisumu, Kenya, Mito Jura Road, Tom Mboya Estate, Off Kisumu-Kakamega Highway.
        • contact_details0736002609,PO BOX 7191-40141,Kisumu
        • contact_personDr. Mark Ayallo
        • site_capacity(null)
        • misc(null)
        • created2025-09-10 18:04:15
        • modified2025-12-16 13:30:02
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id2000
        • application_id1591
        • county_id47
        • site_namePartners for Health and Development in Africa – Sex workers Outreach Program (PHDA – SWOP) Clinic- Nairobi, Kenya
        • physical_addressTransnational Plaza 5th Floor ,Mama Ngina Street
        • contact_details0715684509;PO BOX 3737-00506,Nairobi
        • contact_personDr. Joshua Kimani
        • site_capacity(null)
        • misc(null)
        • created2025-09-10 18:04:15
        • modified2025-12-16 13:30:02
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id866
        • application_id1591
        • sponsorMerck Sharp & Dohme LLC
        • sponsor_typeIndustry
        • contact_personSue Bailey
        • addressMSD(Pty)Ltd,South Africa 117 16th Road,Midrand,1685,Gauteng,South Africa
        • telephone_number+27116553307
        • fax_number
        • cell_number+27116553307
        • email_addresssue.bailey@msd.com
        • created2025-09-10 11:29:28
        • modified2025-12-16 13:30:02
  • 3(array)
    • Application(array)
      • id1188
      • user_id667
      • trial_status_id5
      • abstract_of_study<p>\n Women living with HIV face up to six times increased risk of cervical cancer, and cervical cancer is a leading cause of death in this population. Current approved treatment for high-grade cervical precancer, scientifically termed cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3), is either ablation (cryotherapy or thermal ablation) or excision. Both treatment methods are associated with high rates of CIN2/3 treatment failure in women with HIV,  up to 30% at one year. Studies in high-income countries have demonstrated that off-label use of self-administered, intravaginal 5% 5-FU cream following primary CIN2/3 treatment in HIV-positive women can reduce treatment failure. </p>\n<p>\n This is a single arm pilot study investigating the safety, uptake, tolerability, adherence, and acceptability of off-label self-administered intravaginal 5% fluorouracil (5-FU) cream as adjuvant therapy following primary treatment for CIN2/3 among women living with HIV in Kenya.  Fourteen participants will be enrolled. Participants will self-administer 2 grams of 5% 5-FU cream intravaginally biweekly (every other week, on weeks 1, 3, 5, 7, 9, 11, 13, 15) for a total of 8 applications, and will return to the clinic on weeks 2, 4, 6, 8,10, 12, 14, and 16 for safety and adherence assessments, including a pelvic exam by a trained clinician. Our hypothesis is that adjuvant, self-administered 5% 5-FU cream, used intravaginally at the proposed dose and frequency will be safe, tolerable, and acceptable for use among this population. Our hypothesis is that adjuvant, intravaginal, self-administered 5% 5-FU cream at the proposed dose and frequency will be safe, tolerable, and acceptable for use among this population. This trial, together with data from other studies, will support proceeding to a randomized phase II or phase III trial in Kenya to investigate whether this intervention will reduce CIN2/3 recurrence as has been demonstrated in other settings. </p>\n
      • study_title<p align=\"left\">\n UNCPM  22120: Safety of adjuvant, self-administered intravaginal 5-fluorouracil (5-FU) cream following cervical intraepithelial neoplasia grade 2 and 3 (CIN2/3) treatment among HIV-positive women in Kenya: A pilot study</p>\n
      • laymans_summary<p>\n Women living with HIV are up to six times more likely to get cervical cancer. Cervical cancer screening can identify early changes in the cervix (known as precancer), which can be treated at this early stage. Among women with HIV, the current treatment methods for cervical precancer are not completely effective. Up to 30% of women can continue to have precancer after treatment – known as treatment failure. Because of this, scientists are investigating methods to improve the current cervical precancer treatment methods for women living with HIV. Previous studies in other countries have shown that a medication known as 5-FU, which is available as cream and used to treat skin precancer or cancer, can be used intravaginally after initial cervical precancer treatment in HIV-positive women, to reduce treatment failure. </p>\n<p>\n This study seeks to investigate whether a generic, commonly available chemotherapeutic drug which available as a cream, known as Fluorouracil (5-FU), can be used off-label by women with HIV as an additional, self-administered, intravaginal treatment after the currently approved treatment methods, to reduce cervical precancer treatment failure. The study aims to investigate whether intravaginal 5FU used in this manner is safety, whether many women will want to use it (uptake & acceptability), whether side effects will be few as it has been shown in other studies (tolerability), and whether women will use the medication as instructed (adherence). <strong>This study will last approximately 20 weeks. Women who are enrolled in the study will apply the study medication (5% 5-FU cream) inside the vagina before sleeping once every other week, and they will visit the study clinic on alternative weeks to be monitored for any side effects. Women in the study will keep a calendar of when they use the medication and will write down any symptoms or side effects they have (using a symptom diary), if they are able to read and write. Additionally, all women in the study will be called weekly by a research assistant to report any symptoms they have. Any study participant with concerning symptoms will be seen by a study clinician, and all costs will be covered by the study. At the end of the study, women will be asked about their experience with using the intravaginal treatment. </strong>The information obtained from this study will be used to understand whether 5% 5FU cream can be used off-label widely by more women with HIV following precancer treatment in Kenya and the rest of Africa and the world to improve the effectiveness of current precancer treatment methods. </p>\n
      • short_titleUNCPM 22120 5-FU Study
      • protocol_noECCT/22/11/02
      • version_no1.1
      • date_of_protocol10-02-2023
      • study_drugFluorouracil 5% cream
      • disease_conditionCervical cancer
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_name5-fluorouracil
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrgreshon@kemri-rctp.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGreshon Rota
      • declaration_date118-11-2022
      • declaration_principal_investigatorProf. Elizabeth Bukusi
      • declaration_date218-11-2022
      • placebo_presentNo
      • study_objectives<h2>\n <u>Primary Objective</u></h2>\n<p>\n • To evaluate the safety of 2 grams adjuvant self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment among WLWH in Kenya, used every two weeks. </p>\n<p>\n <br />\n <u>Secondary Objectives</u></p>\n<p>\n 1. To evaluate the uptake of adjuvant, self-administered, intravaginal 5% 5-FU cream following CIN2/3 among WLWH in Kenya. </p>\n<p>\n 2. To evaluate the tolerability of self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment, at the proposed dose and frequency among WLWH in Kenya. </p>\n<p>\n 3. To evaluate adherence to self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment, at the proposed dose and frequency among WLWH in Kenya</p>\n<p>\n 4. To evaluate acceptability of self-administered intravaginal 5% 5-FU cream following CIN2/3 treatment among WLWH in LMICs.<br />\n  </p>\n
      • principal_inclusion_criteria<p style=\"margin-left:36.0pt;\">\n 1.      HIV-positive women (confirmed with serum antibody testing)</p>\n<p style=\"margin-left:36.0pt;\">\n 2.      Age 18 years  – 49 years at enrollment</p>\n<p style=\"margin-left:36.0pt;\">\n 3.      Documentation of a biopsy-confirmed CIN2 or CIN3 </p>\n<p style=\"margin-left:36.0pt;\">\n 4.      Within 4-12 weeks after primary treatment (either cryotherapy, thermal ablation, or loop electrosurgical excision procedure (LEEP)) for CIN2 or CIN3 _</p>\n<p style=\"margin-left:36.0pt;\">\n 5.      Negative pregnancy test at screening</p>\n<p style=\"margin-left:36.0pt;\">\n 6.      Agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation – plus condoms) during the study duration, if of childbearing age. Condoms can be male or female condoms</p>\n<p style=\"margin-left:36.0pt;\">\n 7.      Ability to understand and willingness to sign (or assent when applicable) informed consent </p>\n
      • principal_exclusion_criteria<p style=\"margin-left:43.2pt;\">\n 1.         Unwilling or unable to use birth control during participation in the study</p>\n<p style=\"margin-left:43.2pt;\">\n 2.         History of invasive cervical cancer</p>\n<p style=\"margin-left:43.2pt;\">\n 3.         Known allergy to 5-Fluorouracil</p>\n<p style=\"margin-left:43.2pt;\">\n 4.         History of total hysterectomy</p>\n<p style=\"margin-left:43.2pt;\">\n 5.         Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient</p>\n<p style=\"margin-left:43.2pt;\">\n 6.         Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)</p>\n
      • primary_end_points<p>\n Type, frequency, and severity of AEs.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Principal Investigator and role</strong></p>\n<p>\n  </p>\n<p>\n <strong>Chemtai Mungo, MD, MPH</strong>: Dr. Chemtai Mungo will provide expertise and guidance on protocol development, subject matter expertise, oversee all aspects of protocol implementation, and lead data analysis, interpretation, dissemination of results and future Phase II grant writing and implementation.</p>\n<p>\n  </p>\n<p>\n <strong>Co-Investigators and roles </strong></p>\n<p>\n  </p>\n<p>\n <strong>Elizabeth Bukusi, MBChB, MMed, KEMRI (</strong>Principal Co-Investigator)<strong>:</strong> Dr. Bukusi will provide expertise and guidance on subject matter and protocol implementation, including ethical considerations, collaborative management, study implementation and dissemination of findings.</p>\n<p>\n  </p>\n<p>\n <strong>Lisa Rahangdale, MD, MPH, UNC</strong> (Co-Investigator)<strong>:</strong> Dr. Rahangdale will provide subject matter expertise and guidance on protocol implementation and provide guidance on data analysis, interpretation, dissemination and Phase II grant writing and future work.</p>\n<p>\n  </p>\n<p>\n <strong>Jackton Omoto, MBChB, MMed, Maseno University</strong> (Co-Investigator): Dr. Omoto will provide subject matter expertise, guidance on study design, protocol implementation, as well as support in building capacity of providers to deliver the intervention</p>\n<p>\n  </p>\n<p>\n <strong>Cirillus Ogollah, BSc, DipCM, KEMRI</strong> (Co-Investigator): Mr. Ogollah will play a critical role in managing all study field operations in Kenya and will be involved in data analysis and dissemination of results.</p>\n<p>\n  </p>\n<p>\n <strong>Gershon Rota, B Pharm, KEMRI</strong> (Co-Investigator & Study Pharmacist): Dr. Rota will participate in implementation of study medicine and reporting of adverse effects</p>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p>\n <strong>Michael Hudgens, PhD; UNC (Biostatistician):</strong> Dr. Hudgens will be the lead statistician and provide expertise related to study design, power calculations, data analysis and interpretation.</p>\n
      • other_details_explanation<p>\n The study is an investigator-initiated study targeting HIV-positive women in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 weeks
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaJaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
      • single_site_physical_address614-40100 Kisumu
      • single_site_contact_personCirilus Ogolla
      • single_site_telephone0724717472
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site14
      • total_participants_worldwide14
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
      • investigator1_professional_addressCenter for Microbiology Research, KEMRI, Box 19464, post code 00202, Nairobi
      • investigator1_telephone+254733617503
      • investigator1_emailebukusi@kemri.go.ke
      • organisations_transferred_Yes
      • number_participants14
      • notification
      • approval_date01-03-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-02-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonPI responses to the Querries have ben reviewed and approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2026-04-13 09:46:21
      • created2022-11-15 20:45:16
      • total_sites(null)
      • ecitizen_invoice(null)
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id863
        • application_id1188
        • given_nameElizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
        • professional_addressCenter for Microbiology Research, KEMRI, Box 19464, post code 00202, Nairobi
        • telephone+254733617503
        • emailebukusi@kemri.go.ke
        • investigator_roleprincipal
        • created2022-11-15 21:09:15
        • modified2023-02-13 09:37:27
      • 1(array)
        • id864
        • application_id1188
        • given_nameChemtai
        • middle_name
        • family_nameMungo
        • qualificationMBChB, MPH
        • professional_address3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599, United States
        • telephone+1-919-966-6049
        • emailChemtai_mungo@med.unc.edu
        • investigator_roleprincipal
        • created2022-11-15 21:17:01
        • modified2023-02-13 09:37:27
    • SiteDetail(array)
      • 0(array)
        • id1332
        • application_id1188
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-11-15 21:09:15
        • modified2023-02-13 09:37:27
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id614
        • application_id1188
        • sponsorUniversity of North Carolina OBGYN Department
        • sponsor_typeResearch Institution
        • contact_personBenjamin Chi
        • addressCHAPEL HILL, NC 27599-7570, United States
        • telephone_number+1-919-966-5281
        • fax_number+1-919-966-6049
        • cell_number+1-919-966-5281
        • email_addressinfo@UNCobgyn.org
        • created2022-11-15 21:09:15
        • modified2023-02-13 09:37:27
  • 4(array)
    • Application(array)
      • id1225
      • user_id81
      • trial_status_id1
      • abstract_of_study<p>\n Supplementation with multiple micronutrients has been shown to reduce prevalence of low birth weight and small for gestation age babies when given to pregnant women in nutritionally deficient populations. There are few studies measuring markers of microntrient status in pregnant women in LMICs before and after supplementation but evidence from the JiVita trial in Bangladesh suggests that the current dose formulation is insufficient to achieve repletion. Bangladesh is not a malaria endemic area and deficiencies may vary according to geographic location, hence the need for studies in Kenya.  The proposed trial will be a dose-finding trial of multiple micronutrient supplements in the form of powder to be taken in water with 3 arms: current standard of care and 2 arms: test dose 1 with moderately increased doses and  test dose 2 with higher doses  but below the safe upper level. Pharmacokinetic analysis of micronutrient markers using both rich and sparse sampling timepoints will predict optimal doses. The trial will take place in women of reproductive age aged 18-35 years and consist of 2 cohorts of 108 women: non-pregnant and pregnant women living in 2 locations of Kilifi North subcounty. Tolerability and safety of the supplements will be monitored.</p>\n<p>\n  </p>\n
      • study_title<p class=\"16\" style=\"margin-left:0.0000pt;\">\n <span style=\"font-size:12px;\"><span style=\"font-family: "Times New Roman";\">Optimizing nutrient supplementation among pregnant and reproductive age women in Kenya (Virutubisho)</span></span><span style=\"font-family: "Times New Roman"; font-size: 14pt;\"><o:p></o:p></span></p>\n
      • laymans_summary<p>\n <strong>What is the problem/background?</strong></p>\n<p>\n Deficiencies of essential vitamins and minerals (micronutrients) can occur in women regardless of their weight and may result in poor health, pregnancy outcomes and development and growth of their children. The World Health Organization recommends the use of multiple micronutrient supplements for pregnant women in nutritionally deficient populations, commonly known as UNIMMAP (United Nations International Multiple Micronutrient Antenatal Programme) formulation, to correct deficiencies and improve birth outcomes. The supplement doses are based on the recommended daily intake of healthy populations in North America. Data from supplementation studies in The Gambia and Bangladesh indicate that the dose of micronutrients in UNIMMAP may not be adequate for pregnant women in low-or middle-income countries (LMICs) with inadequate diets. The Kenya National Micronutrient Survey of 2011 reported micronutrient assay results for vitamin A, vitamin B12, folic acid iodine, iron, and zinc but the number of   pregnant women providing samples was small (n=111).</p>\n<p>\n  </p>\n<p>\n <strong>What questions are we trying to answer?</strong></p>\n<p>\n What is the optimal dose of micronutrients to supplement the diet of women of reproductive age and pregnant women in coastal Kenya?</p>\n<p>\n  </p>\n<p>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></p>\n<p>\n The study will take place in Tezo and Ngerenya locations of Kilifi North sub-county. It will involve 216 women aged between 18 to 35 years, 108 non- pregnant and 108 pregnant. The non-pregnant women will be identified from the population census of the Kilifi Health and Demographic Surveillance System (KHDSS) and those identified by community health volunteers and healthworkers. The pregnant women will be selected from the KHDSS census data, those identified by community health volunteers and health workers, and also those attending for antenatal care at Mtondia, and Ngerenya dispensaries in the first 20 weeks of their pregnancy.  </p>\n<p>\n  </p>\n<p>\n <em>Acceptability pre-study</em></p>\n<p>\n In order to choose the most acceptable taste of the supplement, a pre-trial acceptability study of different flavours will be tested on 90 pregnant women volunteers attending antenatal clinic. An interviewer will ask the women to rate each sample on a scale of 1 to 7 according to how much they like or dislike it.  Analysis of the women’s preferences will be used to choose the formulation of the investigational product for the main trial.</p>\n<p>\n  </p>\n<p>\n <em>Evaluation by implementers of the study</em></p>\n<p>\n Up to 30 study staff, health workers, and community health volunteers will take part in workshops and interviews as part of evaluation of implementation of the study. Consent for audio recording will be requested.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<p>\n <em>Acceptability testing of formulations</em></p>\n<p>\n Prior to the main trial, 9 different formulations of the supplement in solution will be tested for taste and acceptability. Ninety pregnant women attending antenatal clinics will be asked for written informed consent to attend a single session where they will each taste 4 of the solutions allocated at random, rate them on a 7 point grading system for acceptability and give their comments on the taste.</p>\n<p>\n  </p>\n<p>\n <em>Screening for eligibility </em></p>\n<p>\n For the main trial women aged 18 to 35 who are interested in participating will be invited to their local dispensary where they will be informed about the study and asked for written consent on screening procedures. They will be asked about their health, medication, and pregnancy status, have their height, weight and mid-upper arm circumference measured, and have a blood sample taken (2ml/half teaspoonful), for full blood count, and biochemistry profile (for kidney and liver function) and a urine sample (5ml/1 teaspoonful) for pregnancy test. Pregnant women will be invited to Kilifi County Hospital for an ultrasound to confirm pregnancy and estimate the gestation of their pregnancy. Results of screening tests will be fed back to women by a fieldworker at their home and those who are eligible will be invited to come to the clinic with their partner or next of kin to hear more about the study procedures.</p>\n<p>\n  </p>\n<p>\n <em>Enrolment</em></p>\n<p>\n At the clinic, women who are eligible will be asked for consent for the study. Those who consent will be enrolled and given an appointment to visit the dispensary for baseline questionnaire and blood sampling (10ml for vitamins and minerals, signs of infection, HIV, malaria, and storage for future studies), urine sampling (5ml) for iodine status assessment and stool (for worms and storage for future studies) tests, before receiving the first dose of supplements. Pregnant women will also have the remaining tests in the standard antenatal profile (blood group, blood glucose, syphilis, and urine protein and glucose) performed from the enrolment samples (same volume).</p>\n<p>\n  </p>\n<p>\n <em>Daily supplements with directly observed treatment</em></p>\n<p>\n The women will be given daily supplements in the form of multiple micronutrient powder dissolved in water. Non-pregnant women will receive supplements for 3 months. and the pregnant women from enrolment (before 20 weeks’ gestation) up to delivery. Women will be randomly allocated to one of 3 dose levels: the control is 1 recommended daily allowance (standard of care) of 15 micronutrients, test dose 1: moderately increased doses of 2 micronutrients or test dose 2: higher doses at safe upper levels of 2 micronutrients. A fieldworker will visit the participant’s home at a convenient time every day with the supplements and observe that they have been taken.</p>\n<p>\n  </p>\n<p>\n <em>Measurement of micronutrient levels </em></p>\n<p>\n Non- pregnant participants will be divided into 2 groups for micronutrient measurement:  the first 36 women will be allocated to the “rich” sampling group which will be sampled at more frequent (5) visits than the remaining 72 women who will be in the less frequent (2 visits) “sparse” sampling group. Women in the rich sampling group will be asked to attend their local dispensary for blood, urine and stool sampling.  For blood and urine sampling, samples will be collected on days 0, 7, 14, 6 weeks and 3 months. Women in the sparse sampling group will be asked to attend their local dispensary for blood, urine and stool sampling at day 0 and 3 months only. The pregnant women will also be divided into more frequent (“rich”, the first 36 women), 7 visits, and less frequent (“sparse” the remaining 72 women) sampling groups, 3 visits, for micronutrient measurement, with rich sampling groups attending on day 0, 7, 14, and 6 weeks, 3 and 5 months and at delivery if giving birth in KCH. The sparse sampling group will be tested at day 0, month 3 and at delivery (KCH).  </p>\n<p>\n Total volumes of blood sampled during the study period for non-pregnant women will be 56 ml (4 tablespoonful) in the rich and 25 ml (2 tablespoonfuls) in the sparse sampling groups. Total volumes of blood sampled during the study period for pregnant women will be 74 ml (5 tablespoonfuls) in the rich and 35 ml (2 tablespoonfuls) in the sparse groups. In addition, 2ml (half teaspoonful) of cord blood will be taken from the umbilical cord of infants born at KCH. The volumes taken during the study are not harmful.</p>\n<p>\n  </p>\n<p>\n <em>Interim safety analysis</em></p>\n<p>\n When the first 36 women of each cohort (non-pregnant and pregnant) have received 6 weeks of supplement, an additional volume of blood (2ml/half teaspoonful) will be taken for rapid analysis of micronutrient levels. The results will be reported to the safety committee overseeing the study.</p>\n<p>\n  </p>\n<p>\n <em>Samples for exploratory outcomes</em></p>\n<p>\n Some of the stool sample, and the cord blood sample will be stored for later analysis.  In addition, in the pregnant women groups a 15ml (3 teaspoonfuls) sample of breastmilk 1 month after delivery will be collected and stored for future analysis.</p>\n<p>\n  </p>\n<p>\n <em>Dietary assessment</em></p>\n<p>\n Women will be visited at home on a monthly basis during supplementation and asked questions on what they have eaten in the previous 24 hours. This will provide information on micronutrient intake from food.</p>\n<p>\n  </p>\n<p>\n <em>Qualitative assessments</em></p>\n<p>\n Interim assessment: When the first 36 participants in each cohort (non-pregnant and pregnant) have received the supplements for 4 weeks they will be invited to group discussions to seek their views on tolerability and acceptability of the supplements and any challenges they faced in participating in the trial. In addition, at the same time, a half day workshop for implementers will be held to get feedback on the progress of the trial. The workshop for implementers will be repeated at the end of the trial. Participants who withdraw from the study will be invited to an indepth interview to explore their reasons for withdrawing.</p>\n<p>\n  </p>\n<p>\n <strong>What are the benefits and risks/costs of the study for those involved? </strong></p>\n<p>\n Participants will receive multiple micronutrient supplements which have known health benefits but have not yet been rolled out in the national antenatal programme. Participants will also have close oversight from the study team and payment of outpatient and inpatient treatment costs for acute illnesses occurring during the study period. Risks of the study include the inconvenience of multiple trips to the dispensary for sampling, and potential for minor discomfort and infection from blood sampling. Daily home visits will be expected to last less than half an hour. Dietary recall interviews (twice monthly), birth and 1month postpartum home visits should each take less than 2 hours. Fares at public transport rate will be reimbursed for all study visits, and out of pocket expenses (500 Kes for study visits lasting more than 3 hours) will be reimbursed.  Potential intolerance of supplementation e.g.  nausea and diarrhoea, will be closely monitored by the study team daily. There is a small potential risk from the micronutrient supplements to the women but doses are below the known safe upper levels in pregnancy. Participants will be followed up for adverse events at each contact with them.</p>\n<p>\n <strong>How will the study benefit society</strong>?</p>\n<p>\n The study will provide new knowledge on optimal dosing of multiple micronutrients for adult women. It will also provide data on nutritional status of adult women in this community.When does the study start and finish?</p>\n<p>\n The study will start upon receipt of ethical and regulatory approval; data collection, analysis and write up will take place over 3 years.</p>\n
      • short_titleMicronutrient supplementation
      • protocol_noECCT/23/03/01
      • version_no3.41
      • date_of_protocol09-01-2023
      • study_drugMultiple micronutrients supplement
      • disease_conditionMicronutrient deficiency
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameMicronutrients
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantFREDRICK OPEL
      • declaration_date128-02-2023
      • declaration_principal_investigatorDR. MARTHA KAENI MWANGOME
      • declaration_date228-02-2023
      • placebo_presentNo
      • study_objectives<p>\n <strong>Objectives</strong><strong>:</strong></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Primary objective:</strong></p>\n<p>\n to determine optimal dosing of multiple micronutrient supplements (MMS) to correct micronutrient deficiencies among pregnant and non-pregnant women of reproductive age in Kilifi County, Kenya</p>\n<p>\n  </p>\n<p>\n <strong>Secondary Objectives: </strong><br />\n i) To describe tolerability and safety of micronutrients at different doses, including birth outcomes</p>\n<p>\n ii) to collect and store infant cord blood and maternal breastmilk for future analysis of micronutrient levels in a separate study</p>\n<p>\n iii) to establish a follow up cohort for evaluation of growth and nutritional status of infants in a separate study</p>\n<p>\n  </p>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<p>\n i) to examine the impact of micronutrient supplementation on the maternal microbiome, inflammatory and physiological markers</p>\n<p>\n ii) to examine effects of maternal genomics on achieving nutrient repletion</p>\n<p>\n iii) to examine infant size at birth and growth to one month of age</p>\n
      • principal_inclusion_criteria<h2>\n <strong>Inclusion criteria</strong></h2>\n<p>\n <strong>Non-pregnant cohort</strong></p>\n<p>\n Women aged 18-35 years</p>\n<p>\n Not pregnant and not lactating</p>\n<p>\n Not intending to move away for 6 months</p>\n<p>\n Negative pregnancy test and not intending to get pregnant during study</p>\n<p>\n Able and willing (in the investigator’s opinion) to comply with all study requirements</p>\n<p>\n <strong>Pregnant women cohort</strong></p>\n<p>\n Women aged 18-35 years</p>\n<p>\n Pregnant with singleton pregnancy from 14 to less than or equal to 20 weeks gestation</p>\n<p>\n Not intending to move away for 6 months</p>\n<p>\n Able and willing (in the investigator’s opinion) to comply with all study requirements</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<h2>\n <strong> Exclusion criteria</strong></h2>\n<p>\n <strong>Non-pregnant women </strong></p>\n<p>\n Known intolerance or allergy to constituents of IP</p>\n<p>\n Moderate or severe anaemia (Hb<8g/dL) or other nutritional conditions requiring immediate treatment</p>\n<p>\n Unwilling to substitute regular MMS for the study product</p>\n<p>\n  </p>\n<p>\n <strong>Pregnant women </strong></p>\n<p>\n Known intolerance or allergy to constituents of IP</p>\n<p style=\"margin-left:-18.0000pt;\">\n Mu  Multiple pregnancy</p>\n<p>\n Moderate or severe anaemia (Hb<7g/dL) or other nutritional conditions requiring immediate treatment</p>\n<p>\n Unwilling to substitute regular MMS for the study product</p>\n<p>\n Foetal concerns suspected at the screening dating ultrasound scan</p>\n
      • primary_end_points<p>\n <u><strong>Primary Endpoint</strong></u></p>\n<p>\n Optimal micronutrient doses will be predicted from PK analysis. The PK model will be used to simulate a dose which achieves concentrations within accepted reference ranges for each micronutrient (<strong>Table 5 of markers of micronutrient status</strong>).</p>\n<p>\n  </p>\n<p>\n Samples will be analysed for haematology (full blood count), biochemistry (Na, K, Ca, Mg, PO₄, albumin, renal and liver function tests), Micronutrient status (zinc, iron, ferritin, transferrin receptor, vitamin B12, folate, vit B6, retinol, beta-carotene, vitamin E, vitamin D, vitamin C, vitamin K, thiamine, riboflavin, niacin, urinary iodide, copper, selenium, calcium, phosphorus, pantothenic acid, biotin, choline, potassium, manganese and magnesium), inflammatory markers (AGP, CRP), and malaria parasites.</p>\n<p>\n  </p>\n<p>\n At delivery or within 48 hours the study staff member will take samples of mother’s blood and urine at the health facility or at a home visit for haematology (full blood count), biochemistry (Na, K, Ca, Mg, PO₄, albumin, renal and liver function tests), micronutrient status (zinc, iron, ferritin, transferrin receptor, vitamin B12, folate, vit B6, retinol, beta-carotene, vitamin E, vitamin D, vitamin C, vitamin K, thiamine, riboflavin, niacin, urinary iodide, copper, selenium, calcium, phosphorus, pantothenic acid, biotin, choline, potassium, manganese and magnesium) inflammatory markers (AGP, CRP) and malaria parasites.</p>\n<p>\n  </p>\n<p>\n If a mother gives birth at KCH and has given consent on the relevant tick box on the ICF a sample of cord blood (2ml) will be obtained and stored for future analysis of micronutrient and inflammatory markers and malaria parasites</p>\n<p>\n  under a separate study protocol.</p>\n<p>\n At 1 month postpartum: 15ml breastmilk will be sampled and stored for future analysis of micronutrients markers, human milk oligosaccharides, exosomes, and proteome. A PhD student will be recruited to explore the effect of MMS on breastfeeding and breastmilk.</p>\n<p>\n  </p>\n<p>\n Samples for haematology, malaria parasites, biochemistry, and inflammatory markers will be analysed at KWTRP laboratories in Kilifi. Samples for micronutrient assays will be sent in batches during and at the end of the intervention to The Metabolomics Innovation Center in Canada because they require specialist equipment not available in Kenya.</p>\n<p>\n <strong>Table </strong><strong>5</strong><strong>: Micronutrient status indicators </strong></p>\n<p>\n  </p>\n<table border=\"0\" cellspacing=\"0\" style=\"width:707px;\">\n <tbody>\n <tr>\n <td style=\"width:89px;\">\n <p>\n <strong>Nutrient</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n <strong>Marker</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n <strong>Cut off for adequacy</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n <strong>Indicator of excess</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n <strong>Notes</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin A</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Retinol µmol/L, β-Carotene, µmol/L</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n serum retinol 0.7 μmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n serum retinol >3.49µmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Blood levels correlate poorly with toxicity, diagnosis is primarily clinical(32)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin D</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n 25 hydroxyVitamin D (25(OH)D nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 25-30nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >200 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n >400 nmol/L associated with hypercalcemia(33)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin E</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n α- tocopherol µmol/L, α- tocopherol: cholesterol ratio µmol/L/mmol</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n α- tocopherol 12 μmol/L; α- tocopherol: cholesterol ratio 2.2 μmol/L/mmol</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no set cut off for toxicity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B1 (Thiamine)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n RBC or whole blood thiamine diphosphate, Erythrocyte transketolase activity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n whole blood thiamine diphosphate 70 nmol/L; ETK activity ratio 1.25</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no marker for excess</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Excess is excreted in urine</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B2 (Riboflavin)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma riboflavin, Erythrocyte glutathione reductase activity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Plasma riboflavin 1mcg/L; EGR activity coefficient 1.4</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no marker for excess</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Excess is excreted in urine</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B3 (Niacin)</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Plasma nicotinic acid plus plasma nicotinamide (µg/mL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 0.5 µg/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n no marker for excess</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n liver transaminases  may rise with extremely high doses(34)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B12</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Total cobalamin pmol/L, Holo-transcobalamin, Methylmalonic acid, Homocysteine</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Total cobalamin 150 pmol/L; methylmalonic acid 0.26 μmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n Total cobalamin >701 pmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Andres (35)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin B6</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n pyridoxal-5’-phosphate nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 20 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >110 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Tynes (36)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Folate</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Total plasma/serum folate nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 10 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >45.3 nmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: WHO (37)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin C</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma ascorbic acid (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 0.4 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >3mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic (38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Iron</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Ferritin µg/L, Transferrin receptor mg/L, TfR:ferritin index mg/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n ferritin 15 μg/L; transferrin receptor 15 μg/L; TfR:ferritin index 2.2</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n Ferritin > 200µg/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Adams (39) </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Zinc</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum zinc (ug/L)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 50 ug/dL in pregnant women</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n  > 110 ug/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic(38) </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Iodine</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Thyroglobulin µg/L, Urinary iodide</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n urinary iodide 150 μg/L pregnant women</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n Urinary iodide≥200ug/L (>250 ug/L in pregnant women)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: WHO (42) >299 excessive risk of adverse health consequences</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Selenium</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum selenium (ng/mL), Glutathione peroxidase activity</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Serum selenium <40 ng/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n serum selenium >150 ng/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic(38) </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Copper</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum copper (ug/mL)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 0.75 ug/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n  >1.45 ug/mL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic (38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Calcium</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Total serum calcium (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 8.5 mg/dL (2.2. mmol/L)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >10.5 mg/dL [2.63 mmol/L]</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: NIH (ODS)(32)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Phosphorus</p>\n </td>\n <td style=\"width:174px;\">\n <p>\n Serum phosphate (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 2.8 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >4.5 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Vitamin K</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Decarboxyprothombin/PIVKA-II (µg/L)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 0.1 µg/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n none established</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n  Pantothenic acid</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma pantothenic acid</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n None Specified</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >147ug/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Mayo Clinic(38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Biotin</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum biotin (mg/dL)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Not defined</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n not established; urinary excretion of biotin</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: NIH (ODS)(32)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Choline</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma choline</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Not defined</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >20 µmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n From: Gossell-Williams(40)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Potassium</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Plasma potassium mmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n 3.5 mmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n >5.5 mmol/L</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Manganese</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum manganese (ug/dL)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:138px;\">\n <p>\n Not defined</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n 3.66 ug/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Mayo Clinic(38)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:89px;\">\n <p>\n Magnesium</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Serum magnesium (mg/dL)</p>\n </td>\n <td style=\"width:138px;\">\n <p>\n 1.7 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:132px;\">\n <p>\n 2.3 mg/dL</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:174px;\">\n <p>\n Mayo Clinic(38)</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table align=\"left\" border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:654px;\" width=\"654\">\n <tbody>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:45px;\">\n <p>\n <strong>Kilifi </strong></p>\n <p>\n  </p>\n <p>\n <strong>Staffing </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:15px;\">\n <p>\n <strong>Staff </strong></p>\n </td>\n <td style=\"width:139px;height:15px;\">\n <p style=\"margin-left:.05pt;\">\n <strong>Names </strong></p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n <strong>Qualifications </strong></p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n <strong>Experience </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:30px;\">\n <p>\n Principal Investigator (1)</p>\n </td>\n <td style=\"width:139px;height:30px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. Martha Mwangome</p>\n </td>\n <td style=\"width:131px;height:30px;\">\n <p style=\"margin-left:.15pt;\">\n M.Sc. PHD (Nutritional Epidemiology).</p>\n </td>\n <td style=\"width:240px;height:30px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, site management and Nutrition Research experience.</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:144px;height:24px;\">\n <p>\n Medical officers (2)</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. James Berkley</p>\n <p>\n  </p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p>\n MBBS MTropMed MRCP MD FRCPCH FMedSci</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, Professor of Paediatrics,</p>\n <p style=\"margin-left:.1pt;\">\n Nutrition Research experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. Alison Talbert</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p style=\"margin-left:.15pt;\">\n MBBS, MRCP, M.Sc. Epidemiology.</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, Nutrition Research experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Pharmacist (1)</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Dr. Jimmy Shangala</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p style=\"margin-left:.15pt;\">\n BPharm, MPharm</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Lab Manager</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p>\n  Jacqueline Waeni</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p>\n M.Sc., PHD-Systems Biology and Bioinformatics (Candidate)</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Lab experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Data Manager</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Narshion Ngao</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p>\n B.Sc. IT, M.Sc. IT</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Research data management experience.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:24px;\">\n <p>\n Study Coordinator</p>\n </td>\n <td style=\"width:139px;height:24px;\">\n <p style=\"margin-left:.05pt;\">\n Fredrick Opel</p>\n </td>\n <td style=\"width:131px;height:24px;\">\n <p style=\"margin-left:.15pt;\">\n B.Sc. Public health, Dip. Clinical Medicine</p>\n </td>\n <td style=\"width:240px;height:24px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trial experience, site management</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:30px;\">\n <p>\n Clinicians (1)</p>\n </td>\n <td style=\"width:139px;height:30px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:30px;\">\n <p>\n Dip. Clinical</p>\n <p style=\"margin-left:.15pt;\">\n Medicine </p>\n </td>\n <td style=\"width:240px;height:30px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical Trials, data collection, site</p>\n <p style=\"margin-left:.1pt;\">\n management, Ultrasonography.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:30px;\">\n <p>\n Nurses (3)</p>\n </td>\n <td style=\"width:139px;height:30px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:30px;\">\n <p>\n Dip. Nursing</p>\n </td>\n <td style=\"width:240px;height:30px;\">\n <p style=\"margin-left:.1pt;\">\n Clinical trials, sample collection and management</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"height:14px;\">\n <p>\n Senior Field worker (2)</p>\n </td>\n <td style=\"width:139px;height:14px;\">\n <p style=\"margin-left:.05pt;\">\n Nichodemus Wara</p>\n </td>\n <td style=\"width:131px;height:14px;\">\n <p style=\"margin-left:.15pt;\">\n KCSE</p>\n </td>\n <td style=\"width:240px;height:14px;\">\n <p style=\"margin-left:.1pt;\">\n Data collection, team lead, field work, data entry, Rider,</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:139px;height:14px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:14px;\">\n <p style=\"margin-left:.15pt;\">\n KSCE</p>\n </td>\n <td style=\"width:240px;height:14px;\">\n <p style=\"margin-left:.1pt;\">\n Data collection, team lead, field work, data entry, Rider</p>\n </td>\n </tr>\n <tr>\n <td style=\"height:15px;\">\n <p>\n Field worker (18)</p>\n </td>\n <td style=\"width:139px;height:15px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n KCSE</p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n Data collection, field work, data entry, Rider,</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:144px;height:15px;\">\n <p>\n Senior Data Supervisor (2)</p>\n </td>\n <td style=\"width:139px;height:15px;\">\n <p style=\"margin-left:.05pt;\">\n Amos Fondo</p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n BSc. Computer Science</p>\n <p style=\"margin-left:.15pt;\">\n  </p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n Data entry, data cleaning, query management</p>\n <p style=\"margin-left:.1pt;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:139px;height:15px;\">\n <p>\n Eunice Kahindi</p>\n </td>\n <td style=\"width:131px;height:15px;\">\n <p style=\"margin-left:.15pt;\">\n BSc. Computer Science</p>\n </td>\n <td style=\"width:240px;height:15px;\">\n <p style=\"margin-left:.1pt;\">\n Data entry, data cleaning, query management</p>\n <p style=\"margin-left:.1pt;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;height:37px;\">\n <p>\n Lab technologist (1)</p>\n </td>\n <td style=\"width:139px;height:37px;\">\n <p style=\"margin-left:.05pt;\">\n To be identified</p>\n </td>\n <td style=\"width:131px;height:37px;\">\n <p>\n Dip. Lab technology</p>\n </td>\n <td style=\"width:240px;height:37px;\">\n <p>\n Microbiology, AST testing, biorepository in a research Lab.</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:74px;\">\n <p>\n <strong>Site Facilities </strong></p>\n <ul>\n <li>\n Office space with adequate resources i.e. furniture, internet connectivity and computers</li>\n <li>\n Well-spaced clinical rooms and phlebotomy unit.</li>\n <li>\n Access to Programme transport for community follow up and administration of DOTs.</li>\n <li>\n Laboratory network – Full microbiology, hematology, parasitology, and immunology.</li>\n <li>\n Kilifi County Hospital: Maternity ward, acute room, maternal and child health clinic, Mtondia and Ngerenya dispensaries</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:45px;\">\n <p>\n <strong>Emergency facilities </strong></p>\n <p>\n - Access to Kilifi Level 5 County Referral Hospital with ICU.</p>\n <p style=\"margin-left:.25in;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:654px;height:74px;\">\n <p>\n <strong>Other Infrastructure </strong></p>\n <ul>\n <li>\n Demographic surveillance System (DSS)</li>\n <li>\n Community Liaison Department</li>\n <li>\n Access to hospital OBS/GYN consultants and other county health staff.</li>\n </ul>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study is being conducted in the same host country as the applicant.</p>\n
      • other_details_regulatory_notapproved<p>\n NONE.</p>\n
      • other_details_regulatory_approved<div>\n 1. The KEMRI Scientific and Ethics Review Unit</div>\n<div>\n (SERU) 23 Jan 2023.</div>\n<div>\n  </div>\n<div>\n <div>\n 2.Oxford Tropical Research Ethics Committee, 31st Jan 2023.</div>\n <p>\n  </p>\n <p>\n Approval granted for one site in Kilifi, Kenya.</p>\n</div>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n NONE.</p>\n
      • other_details_regulatory_halted<p>\n NOT APPLICABLE.</p>\n
      • estimated_duration36 MONTHS.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorUNIMMAP WITH 60 MG IRON.
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKILIFI
      • single_site_physical_addressKEMRI CENTRE FOR GEOGRAPHIC MEDICAL RESEARCH -COAST, OFF BOFA ROAD, INSIDE KILIFI COUNTY HOSPITAL COMPOUND, KILIFI.
      • single_site_contact_personDR. MARTHA MWANGOME
      • single_site_telephone0722203417
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site216
      • total_participants_worldwide216
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailMMwangome@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants216
      • notification<p>\n NONE.</p>\n
      • approval_date24-07-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-05-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer responses have been addressed adequately
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2026-01-29 11:28:22
      • created2023-02-08 14:05:32
      • total_sites(null)
      • ecitizen_invoice(null)
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id899
        • application_id1225
        • given_nameDR. Martha
        • middle_nameKaeni
        • family_nameMwangome
        • qualificationPHD
        • professional_addressKILIFI WELLCOME TRUST , P.O BOX 230
        • telephone0722203417
        • emailmmwangome@kemri-wellcome.org
        • investigator_roleprincipal
        • created2023-02-08 14:13:56
        • modified2023-05-15 07:58:47
    • SiteDetail(array)
      • 0(array)
        • id1450
        • application_id1225
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2023-02-08 14:13:56
        • modified2023-05-15 07:58:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id640
        • application_id1225
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personSAMI KELSH
        • addressBoundary Brook House, Churchill Drive, Oxford OX3 7LQ
        • telephone_number+44 1865 70000
        • fax_number
        • cell_number+44 1865 70000
        • email_addressresearch.services@admin.ox.ac.uk
        • created2023-02-08 14:13:56
        • modified2023-05-15 07:58:47
• page_options(array)
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  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
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  • Application(empty)
  • User(empty)
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  • InvestigatorContact(empty)
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  • SiteDetail(empty)
  • County(empty)
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  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
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App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

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