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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id573
      • user_id81
      • trial_status_id8
      • abstract_of_study<p>\n Children with complicated severe acute malnutrition (SAM) admitted to hospital in sub-Saharan Africa have a case fatality between 12% and more than 20%. Because children with SAM may not exhibit the usual signs of infection, WHO guidelines recommend routine antibiotics. However, this is based on “low quality evidence”. There is evidence from CGMR-C, Kilifi and from other centres in Africa that bacterial resistance to the currently recommended first-line antibiotics (gentamicin plus ampicillin or penicillin) may be less effective than potential alternatives. Some hospitals in Africa are already increasing use of ceftriaxone as a first-line treatment. However, this is not based on any data that ceftriaxone actually improves outcomes. Of concern is that ceftriaxone use may also lead to increased antimicrobial resistance, including inducing extended spectrum beta-lactamase (ESBL) and other classes of resistance. We are currently undertaking a study to assess the prevalence of carriage of bacteria expressing ESBL (KEMRI/SERU/CGMR-C/023/3161; OxTREC 47-15). A further area where evidence for policy is lacking is the use of metronidazole in severely malnourished children. The WHO guidelines recommend “Metronidazole 7.5 mg/kg every 8 h for 7 days may be given in addition to broad-spectrum antibiotics; however, the efficacy of this treatment has not been established in clinical trials.” Metronidazole is effective against anaerobic bacteria, small bowel bacterial overgrowth, Clostridium difficile colitis and also Giardia, which is common amongst children with SAM. Small cohort studies of metronidazole usage suggest there may be benefits for nutritional recovery in malnourished children. However, metronidazole can cause nausea and anorexia, potentially impairing recovery from malnutrition and may also rarely cause liver and neurological toxicity. This multicentre clinical trial will assess the efficacy of two interventions, ceftriaxone and metronidazole, on mortality and nutritional recovery in sick, severely malnourished children in a 2x2 factorial design. There will also be an analysis of antimicrobial resistance and an economic analysis. To extend our understanding of metronidazole and ceftriaxone pharmacokinetics from protocol KEMRI/SERU/CGMR-C/023/3161; OxTREC 47-15’, additional pharmacokinetic data for the dosing schedule used in the trial will be collected from 120 participants. The trial will be conducted at Kilifi County Hospital, Coast General Hospital, Mbagathi Hospital in Kenya and Mbale Regional Referral Hospital in Uganda. The trial will assess antimicrobial resistance that is carried by children in their intestines and in invasive bacterial isolates. The relative costs of care for SAM for health facilities and for families, including antimicrobial usage will also be assessed. Clear data on the benefits, risks and costs of these antimicrobials will influence policy on case management and antimicrobial stewardship in this vulnerable population.  </p>\n
      • study_title<p>\n First Line Antimicrobials in Children with Complicated Severe Acute Malnutrition</p>\n
      • laymans_summary<h4>\n Lay Title</h4>\n<p>\n A study to compare antibiotics used to treat children with severe acute malnutrition.</p>\n<h4>\n What is the problem?</h4>\n<p>\n Children with severe malnutrition who are admitted sick to hospitals have a high mortality, usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics. However, we are not sure that the current antibiotics are the most effective. It is possible that the antibiotics that are currently used as second-line should be used first. No studies have been carried out to determine if the current antibiotics used for treating malnourished children are the most appropriate. We will therefore carry out this large trial comparing different antibiotics to find out this.</p>\n<h4>\n What questions are we trying to answer?</h4>\n<p>\n We want to find out if a revised antibiotic regime for children with complicated severe acute malnutrition is safe, reduces the risk of death and improves nutritional recovery. We also want to find out how often children carry bacteria that are resistant to antibiotics in their intestines and the effects of different antibiotics on the ability for bacteria to resist antibiotic treatment and the costs to hospitals and to families of treating malnourished (SAM) and without SAM children with the different antibiotics.</p>\n<h4>\n Where is the study taking place, how many people does it involve and how are they selected?</h4>\n<p>\n We will carry out the study in Kilifi County Hospital, Coast General Hospital in Mombasa, and Mbagathi hospital in Nairobi, Kenya and Mbale Regional Referral Hospital, Uganda. We will enrol 2,000 children with severe malnutrition admitted to hospital. We will ask parents and guardians of all children between the ages of 2 months to 13 years who are admitted to hospital with severe malnutrition and would normally be treated with antibiotics according to current guideline to participate and enrol an equal number of children at each site who are admitted without SAM to examine faecal samples for bacteria that may be resistant to antibiotics.</p>\n<h4>\n What does the study involve for those who are in it?</h4>\n<p>\n After informed consent, a study clinician will examine the child and prescribe antibiotics that have been randomly allocated. A small volume of blood and a faecal sample will be taken for this research in addition to the routine tests for care at admission before antibiotic administration, and again at discharge. The children will be reviewed daily by the study team, working together with the hospital staff to provide the best care available in the hospital. Children will be followed up for 90 days from enrolment with 3 scheduled follow up visits involving a health questionnaire, anthropometry and the collection of a faecal sample at two of the visits. The levels of the antibiotics being used will be checked in the blood of 120 participants at Kenyan sites whilst in hospital. Parents and carers of approximately 650 children in both SAM and without SAM across all sites may also be interviewed about any costs they have met as a result of the child needing healthcare. If a child requires readmission to hospital, a small volume of blood will be drawn to try and determine the cause. Results of blood tests will be fed back to the clinical team to assist in care. For non-severely malnourished children, a rectal swab will be taken at admission and discharge, and information collected during admission, but we will do no additional samples or further follow up.</p>\n<h4>\n  </h4>\n<p>\n  </p>\n<p>\n  </p>\n<h4>\n What are the benefits and risks/costs of the study for those involved? </h4>\n<address>\n Training will be enhanced for all paediatric ward staff on treatment of sick and malnourished children and assisting with control of infections within the hospitals. Drawing a blood sample carries the risks of discomfort and damage to the vein or infection; careful procedures including cleaning the skin will help prevent these. Rectal swabs and faeces collection have minimal risk. Travel costs and lost earnings associated with scheduled follow up visits will be reimbursed, based on national guidelines.</address>\n<h4>\n How will the study benefit society? </h4>\n<p>\n Knowing how better to use antibiotics in malnourished children when they are admitted to hospital will help decision-making to improve their health and survival. The findings from this research will directly inform policy and program management decisions related to the care of the sick child.</p>\n<h4>\n When does the study start and finish?</h4>\n<address>\n The study aims to start as soon as scientific and ethical approval is granted, follow up for participants is expected to continue for about 3 years and the overall study for about 5 years.</address>\n<p>\n  </p>\n
      • short_titleFLACSAM
      • protocol_noECCT/17/03/03
      • version_no1.04
      • date_of_protocol20-03-2019
      • study_drugCeftriaxone, Metronidazole, Penicillin, Gentamicin
      • disease_conditionSevere Acute Malnutrition
      • 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_nameCeftriaxone, Metronidazole, Penicillin, Gentamycin, Metronidazole placebo
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@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_countries1
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
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      • applicant_prev_data0
      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantNancy Kagwanja
      • declaration_date120-03-2017
      • declaration_principal_investigatorProf. Jay Berkley
      • declaration_date220-03-2017
      • placebo_presentYes
      • study_objectives<h2>\n 1.1Null hypotheses</h2>\n<ul>\n <li>\n Mortality amongst children admitted to hospital with complicated SAM is not altered by administration of intravenous ceftriaxone or metronidazole as first line agents compared to penicillin plus gentamicin.</li>\n</ul>\n<h2>\n Primary objective</h2>\n<p>\n Amongst children with complicated SAM, to establish whether:</p>\n<ul>\n <li>\n Mortality is reduced during 90 days when treated with broader spectrum first-line antibiotics (ceftriaxone or metronidazole), compared to the currently recommended narrower spectrum antibiotics (penicillin and gentamicin).</li>\n</ul>\n<h2>\n Secondary objectives</h2>\n<p style=\"margin-left:36.0pt;\">\n To evaluate in trial participants:</p>\n<ul>\n <li>\n Suspected grade 4 toxicity and serious adverse events</li>\n <li>\n Mortality in hospital and after discharge</li>\n <li>\n Duration of hospitalisation and antimicrobial administration</li>\n <li>\n Frequency and causes of readmission to hospital during follow up</li>\n <li>\n Recovery of nutritional status during follow up</li>\n <li>\n Aetiology of infections occurring during the study and faecal carriage of bacteria expressing Extended Spectrum Beta Lactamase (ESBL), at admission, discharge and follow up</li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<h3>\n ·Inclusion criteria – clinical trial participants (SAM)</h3>\n<ul>\n <li>\n Age 2 months to 13 years inclusive</li>\n <li>\n Severe malnutrition defined as: kwashiorkor; or MUAC <11.5cm in children in children between 6 to 59 months or MUAC <11cm in children aged 2 to 59 months; or weight-for length Z score <-3; or  BMI-for-age Z score <-3 or MUAC <11.5cm in children aged 5 to 13 years.</li>\n <li>\n Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines</li>\n <li>\n Planning to remain within the hospital catchment area and willing to come for specified visits during the 90 day follow up period</li>\n <li>\n Informed consent provided by the parents/guardian</li>\n</ul>\n<h3>\n ·Inclusion criteria - antimicrobial pharmacokinetics (SAM)</h3>\n<ul>\n <li>\n A convenience sample of the children with SAM enrolled in the trial during normal working hours</li>\n</ul>\n<h3>\n ·Inclusion criteria – non-trial participants for faecal carriage of resistance (without SAM)</h3>\n<ul>\n <li>\n Age 2 months to 13 years inclusive</li>\n <li>\n Without SAM (as defined above) and admitted during normal working hours</li>\n <li>\n Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines</li>\n <li>\n Informed consent provided by the parents/guardian</li>\n</ul>\n<p>\n <br />\n  </p>\n
      • principal_exclusion_criteria<h3>\n ·Exclusion criteria – clinical trial participants (SAM)</h3>\n<ul>\n <li>\n Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or metronidazole</li>\n <li>\n A specific and documented clinical indication for another class of antibiotic</li>\n <li>\n Previously enrolled in this study</li>\n</ul>\n<h3>\n ·Exclusion criteria – non-trial participants for faecal carriage of resistance (without SAM)</h3>\n<p>\n Previously enrolled in this study</p>\n
      • primary_end_points<ul>\n <li>\n Mortality -(ceftriaxone), compared to the currently recommended narrower spectrum antibiotics (penicillin and gentamicin).</li>\n <li>\n Mortality-oral metronidazole, compared to placebo.</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • 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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n <strong>Site</strong></td>\n <td>\n <strong>Name</strong></td>\n <td>\n <strong>Qualification</strong></td>\n <td>\n <strong>Experience</strong></td>\n </tr>\n <tr>\n <td>\n Kilifi</td>\n <td>\n Prof. James Berkley</td>\n <td>\n Professor of Paediatric  Infectious Diseases</td>\n <td>\n Prinicipal Investigator, Paediatric Consultant in infectious diseases</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Dr Neema Mturi</td>\n <td>\n MBChB</td>\n <td>\n Consultant Paediatrician</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Dr Caroline Ogwang</td>\n <td>\n MBChB, MsC Epidemiology</td>\n <td>\n Clinical trials experience, Lead clinician, Care of severely malnourished children,</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Nancy Kagwanja</td>\n <td>\n BScN, MPH</td>\n <td>\n Clinical Trials Coordination, Monitoring, quality assurance</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Sheila Murunga</td>\n <td>\n BSc Computer Science and Statistics</td>\n <td>\n Data management, analysis</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Joseph Waichungo</td>\n <td>\n Bsc Medical Laboratory Sciences, Registered Laboratory Technician</td>\n <td>\n Medical microbiology diagnostics and quality assurances, sampling, Sample processing and sample management,</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Johsntone Thitiri</td>\n <td>\n BScN, MSc Clinical Trials</td>\n <td>\n Clinical Trial Coordination, Monitoring, quality assurance</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Jimmy Shangala</td>\n <td>\n Bsc Pharmacy</td>\n <td>\n Clinical Trials Pharmacy, Vaccine product management, oversight on investigational products at clinical trial sites</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Shalton Mwaringa</td>\n <td>\n HND-Paediatrics, Registered Clinical Officer</td>\n <td>\n Site lead clinician, Clinical trial experience, Care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Rehema Ali</td>\n <td>\n KRCHN, MSc Clinical Trials</td>\n <td>\n <p>\n Study nurse, clinical trial experience,<br />\n Care of severely malnourished children</p>\n </td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Grace Dena</td>\n <td>\n Registered Clinical Officer, MSc Clinical Trials</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Mwanamvua Boga</td>\n <td>\n KRCHN, MSc Clinical Trials</td>\n <td>\n Nurse manager, clinical trials expereince, care of critically ill children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Prof. Kathryn Maitland</td>\n <td>\n Professor of Paediatric Tropical Infectious Diseases</td>\n <td>\n Paediatric Consultant on Infectious Diseases</td>\n </tr>\n <tr>\n <td>\n Coast General Hospital</td>\n <td>\n Dr Victor Bandika</td>\n <td>\n MBChB, MMed Paediatrics</td>\n <td>\n Paediatric consultant</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Laura Mwalekwa</td>\n <td>\n HND-Paediatrics, Registered Clinical Officer</td>\n <td>\n Site Lead clinician, clinical trials experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Fauzat Hamid</td>\n <td>\n Registered Clinical Officer</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n John Paul Odhiambo</td>\n <td>\n Registered Clinical Officer</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Jones Makori</td>\n <td>\n BSc Pharmacy, MSc, Pharmacoepidemiology</td>\n <td>\n Site Pharmacist,</td>\n </tr>\n <tr>\n <td>\n Mbagathi</td>\n <td>\n Dr Christine Manyasi</td>\n <td>\n MBChB, MMed-Paediatrics</td>\n <td>\n Paediatric consultant</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Molline Timbwa</td>\n <td>\n HND-Paediatrics, Registered Clinical Officer,</td>\n <td>\n Site Lead Clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Joshua Wambua</td>\n <td>\n Registered Clinical Officer</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n Mbale Regional Referral Hospital, Uganda</td>\n <td>\n Dr Peter Olupotolupot</td>\n <td>\n MBChB, MPH, PHD</td>\n <td>\n Local principal investigator, clinical trial experience, care of critically ill children</td>\n </tr>\n <tr>\n <td colspan=\"4\">\n <p>\n Each site will be supported by a clinical team comprising of the hospital's paediatric consultant and study clinicians, a nurisng team and fieldworkers with experience in clinical research and communication with patients and study participants.</p>\n <p>\n Kilifi County Hospital and Mbagathi Hospital are level 4 hospitals with sufficient emergency facilities and infrastructure for patient referral. Kilifi Hospital also has a High Dependency Unit in it's paediatric department. Coast General Hospital is a level 5 hospital with efficient emergency facilities, a paediatric observation ward and facilities to provide acute care. Mbale Hospital is a regional referral hospital. Within it's paeaditric department it also has a High Dependency Unit for patients requiring critical care.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n In Uganda, the protocol was submitted and approved by National Drug Authority (NDA).</p>\n
      • other_details_regulatory_approved<p>\n NDA- In Uganda and UNCST</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationThe trial enrolment and follow up will be conducted during a period of 3 years. A further 2 years will be required for analysis, dissemination and to complete the secondary laboratory analyses.
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyThe trial will investigate two separate antimicrobial interventions in a 2x2 factorial design randomised controlled clinical trial. Two randomisations will be made. The two interventions will be analysed separately.
      • design_controlled_comparatorStandard of Care-(penicil
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • 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_states2
      • number_of_sites3
      • multi_country_listKenya\nUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment--Minimum number per site 300, Maximum number per site- 1000
      • total_participants_worldwide2000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren aged between 2 months and 13 years inclusive. They will require their parent(s)/guardian(s) consent to participate in the study.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJames
      • investigator1_middle_name
      • investigator1_family_nameBerkley
      • investigator1_qualificationProfessor of Paediatric Infectious Diseases
      • investigator1_professional_addressKEMRI Wellcome Trust Research Programme, P.O BOX 230-80108 Kilifi
      • investigator1_telephone+254 720867011
      • investigator1_emailJBerkley@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants1300
      • notification<p>\n None</p>\n
      • approval_date21-06-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-03-2020
      • 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)
      • modified2022-10-31 11:27:09
      • created2016-11-29 11:57:26
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id369
        • application_id573
        • given_nameJames
        • middle_name
        • family_nameBerkley
        • qualificationProfessor of Paediatric Infectious Diseases
        • professional_addressKEMRI Wellcome Trust Research Programme, P.O BOX 230-80108 Kilifi
        • telephone+254 720867011
        • emailJBerkley@kemri-wellcome.org
        • created2016-11-29 12:43:14
        • modified2020-03-07 13:40:56
    • SiteDetail(array)
      • 0(array)
        • id452
        • application_id573
        • county_id3
        • site_nameKilifi County Hospital
        • physical_addressBahari off Bofa Road, P.O BOX 9-80108 Kilfi
        • contact_detailsP.O BOX 9-80108 Kilfi
        • contact_personCaroline Ogwang
        • site_capacity(null)
        • misc(null)
        • created2016-11-29 12:43:14
        • modified2020-03-07 13:40:56
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 1(array)
        • id453
        • application_id573
        • county_id1
        • site_nameCoast General Hospital
        • physical_addressBondeni, Kisauni Road, Mombasa
        • contact_detailsMombasa, 80100
        • contact_personLaura Mwalekwa
        • site_capacity(null)
        • misc(null)
        • created2016-11-29 14:11:43
        • modified2020-03-07 13:40:56
        • County(array)
          • id1
          • county_nameMombasa
          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
      • 2(array)
        • id454
        • application_id573
        • county_id47
        • site_nameMbagathi Hospital
        • physical_address Kenyatta N. Hospital Golf Course Estate, Nairobi, Kenya ...
        • contact_details P.O.Box: 20725-00202, Nairobi
        • contact_personMolly Timbwa
        • site_capacity(null)
        • misc(null)
        • created2016-11-29 15:21:00
        • modified2020-03-07 13:40:56
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id295
        • application_id573
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personProf. Jay Berkley
        • addressKEMRI Wellcome Trust Research Programme, P.O BOX 230-80108 Kilifi
        • telephone_number+254790200170
        • fax_number
        • cell_number+254 720867011
        • email_addressJBerkley@kemri-wellcome.org
        • created2016-11-29 12:43:14
        • modified2020-03-07 13:40:56
      • 1(array)
        • id296
        • application_id573
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personProf. James Berkley
        • addressKEMRI Wellcome Trust Research Programme, P.O BOX 230-80108 Kilifi
        • telephone_number+254790200170
        • fax_number
        • cell_number+254790200170
        • email_addressJBerkley@kemri-wellcome.org
        • created2016-11-29 14:11:43
        • modified2020-03-07 13:40:56
  • 1(array)
    • Application(array)
      • id601
      • user_id611
      • trial_status_id2
      • abstract_of_study<p>\n The clinical presentation of pediatric venous thromboembolic (VTE) disease includes many manifestations, such as catheter-related thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and sinovenous thrombosis. The majority of pediatric subjects (> 95%) with VTE have at least 1 clinical risk factor. Currently, the presence of a central venous catheter is the most important acquired trigger for the development of venous thromboembolic disease in pediatric subjects, contributing to > 90% of all neonatal thrombi and more than half of all thrombi in the older children. Several mechanisms play a role in the development of catheter related thrombosis, including vessel wall injury by the catheter or infused substances (especially parenteral nutrition), compromised blood flow, and thrombogenic effects of the catheter material. Catheter-related thrombi develop in children with long-term venous access devices for diseases such as malignancy, intestinal failure, renal insufficiency, and cystic fibrosis and in children with short-term catheters on the intensive care unit or for cardiac catheterization. Other important risk factors for pediatric thrombosis are congenital heart disease, surgery, immobilization, malignancy, nephrotic syndrome, sepsis, and estrogen treatment. The presence of congenital prothrombotic disorders contribute to the development of pediatric venous thrombosis, as well. Increasing numbers of pediatric subjects with chronic diseases will require anticoagulation as the incidence of VTE events rises due to hypercoagulability and the use of central venous catheters. Currently, the majority of pediatric thrombi are treated with low molecular weight heparin (LMWH) or unfractionated heparin (UFH) followed by LMWH or vitamin K antagonists (VKAs) for a total of 3 to 6 months11. More recently, data exists for the use of fondaparinux in children. Subjects should receive LMWH, UFH, or fondaparinux for at least 5 days following diagnosis of VTE. Guidelines recommend starting VKA on the first treatment day because of slow onset of action. LMWH, UFH, or fondaparinux may be discontinued when the VKA has reached its therapeutic level, as indicated by an international normalized ratio (INR) ≥ 2.0 for 2 or more measurements at least 24 hours apart. Many pediatric subjects have severe underlying diseases which preclude early oral treatment and thus LMWH is continued. In children, the outcome of venous thromboembolic disease has been reported in several studies. The REVIVE trial, a randomized controlled trial comparing LMWH with UFH and VKAs showed a direct mortality rate of 0% in both groups after 3 months. In the Canadian outcome study mortality as result of thrombosis was 2.2%. In the REVIVE trial, recurrent thrombosis occurred in 12.5% of the subjects in the UFH/VKA group and 5.6% in the LMWH group after 3 months of treatment. The recurrence-free survival after 6 months was 93% in pediatric subjects of one center in the Netherlands. Most subjects were treated with LMWH or UFH followed by VKAs. Merkel et al followed 27 subjects treated with LMWH. After a mean time of 2.3 years (range: 0.5 – 6.25 years), 55.6% of the subjects showed complete resolution with radiographic tests, 29.6% partial resolution, and 14.8% no resolution. Newall et al studied radiographic outcome of 22 infants (< 6 months old) and 73 children (≥ 6 months old) after 5 days to 4.2 years. In infants and children, complete resolution occurred in 53% and 47%, partial resolution in 29% and 36%, and no resolution or extension in 18% and 17%, respectively. Post-thrombotic syndrome (PTS) is a manifestation of chronic venous insufficiency following DVT. Children with PTS must endure chronic sequelae for many decades. Goldenberg et al showed that PTS occurrence varied widely (< 10% to 70%) depending on the scoring system; the calculated mean frequency of PTS was 26% (95% confidence interval [CI]: 23% to 28%) among a total of nearly 1000 subjects with upper extremity (UE)/lower extremity (LE) DVT. In the cross-sectional study, multiple logistic regression analysis revealed that lack of thrombus resolution was associated with a statistically significant 4 fold increase in odds of PTS. Therefore we propose to evaluate edoxaban on the reduction of thrombotic burden defined by “no change and extension” of the thrombus at the month 3 visit. Edoxaban is an oral direct inhibitor of activated Factor X with predictable pharmacokinetics (PK) and pharmacodynamics (PD). As a result, anticoagulant effects are more likely to remain within the therapeutic range, thereby decreasing the likelihood of bleeding, and potentially removing the need for dose adjustment or frequent monitoring. These advantages may result in increased patient satisfaction and adherence compared with existing anticoagulants Edoxaban has been approved for the following indications in the US: • To reduce the risk of stroke and systemic embolism (SE) in subjects with nonvalvular atrial fibrillation (NVAF) with limitation of use in patients with CrCL > 95 mL/min. • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant. In the EU and Japan, edoxaban has been approved for the following indications: • Prevention of stroke and systemic embolism in adult subjects with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA) with no limitation of use. • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults . This study will evaluate the benefits and risks of edoxaban in pediatric subjects with thromboembolic disease.</p>\n
      • study_title<p>\n A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, CONTROLLED TRIAL TO EVALUATE THE PHARMACOKINETICS AND PHARMACODYNAMICS OF EDOXABAN AND TO COMPARE THE EFFICACY AND SAFETY OF EDOXABAN WITH STANDARD OF CARE ANTICOAGULANT THERAPY IN PEDIATRIC SUBJECTS FROM BIRTH TO LESS THAN 18 YEARS OF AGE WITH CONFIRMED VENOUS THROMBOEMBOLISM (VTE)</p>\n
      • laymans_summary<p>\n The clinical presentation of pediatric venous thromboembolic (VTE) disease includes many manifestations, such as catheter-related thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and sinovenous thrombosis. The majority of pediatric subjects (>95%) with VTE have at least 1 clinical risk factor. Currently, the presence of a central venous catheter is the most important acquired trigger for the development of venous thromboembolic disease in pediatric subjects, contributing to >90% of all neonatal thrombi and more than half of all thrombi in the older children1, 2 3, 4. Several mechanisms play a role in the development of catheter related thrombosis, including vessel wall injury by the catheter or infused substances (especially parenteral nutrition), compromised blood flow, and thrombogenic effects of the catheter material5. Catheter-related thrombi develop in children with long-term venous access devices for diseases such as malignancy, intestinal failure, renal insufficiency, and cystic fibrosis and in children with short-term catheters on the intensive care unit or for cardiac catheterization6, 7, 8. Other important risk factors for pediatric thrombosis are congenital heart disease, surgery, immobilization, malignancy, nephrotic syndrome, sepsis, and estrogen treatment. The presence of congenital prothrombotic disorders contribute to the development of pediatric venous thrombosis, as well9. Increasing numbers of pediatric subjects with chronic diseases will require anticoagulation as the incidence of VTE events rises due to hypercoagulability and the use of central venous catheters1</p>\n<p>\n <br />\n  </p>\n
      • short_titleThe Edoxaban Hokusai VTE PEDIATRICS Study
      • protocol_noECCT/17/03/02
      • version_noVERSION 1.0
      • date_of_protocol16-04-2016
      • study_drugEdoxaban (DU-176b)
      • disease_conditionTreatment and secondary prevention of VTE
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameStandard of care (SOC; including low Molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors)
      • comparator_registeredyes
      • comparator_countriesworldwide
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressMshitindo@strathmore.edu
      • 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_countries1
      • 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_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantAmina Salim
      • declaration_date116-03-2017
      • declaration_principal_investigatorBernhards Ogutu Ragama
      • declaration_date216-03-2017
      • placebo_presentNo
      • study_objectives<p>\n The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent VTE, death as result of VTE, and no change or extension of thrombotic burden) during the first 3-month treatment period.</p>\n
      • principal_inclusion_criteria<p>\n <strong>Subject Eligibility Criteria: Inclusion Criteria: </strong></p>\n<p>\n Subjects must satisfy all of the following criteria to be included in the study:</p>\n<p style=\"margin-left:.25in;\">\n 1.� � � Male or female pediatric subjects between birth (defined as 38 weeks gestational age) and less than</p>\n<p style=\"margin-left:.25in;\">\n 18 years of age at the time of consent.</p>\n<p style=\"margin-left:.25in;\">\n 2.� � � Pediatric subjects with the presence of documented VTE confirmed by appropriate diagnostic imaging and requiring anticoagulant therapy for at least 90 days (list of VTE provided in Section 7.1).</p>\n<p style=\"margin-left:.25in;\">\n 3.� � � Subjects must have received at least 5 days of heparin (LMWH or SP Xa inhibitors or UFH according to the edoxaban label for VTE treatment) therapy prior to randomization to treat the newly identified index VTE. In addition, prior to being randomized to edoxaban or SOC, subjects initially treated with VKA are recommended to have an INR < 2.0.</p>\n<p style=\"margin-left:.25in;\">\n 4.� � � Subject and/or parent(s)/legal guardian(s) or legally acceptable representative is informed and provides signed consent for the child to participate in the study with edoxaban treatment. Pediatric subjects with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.</p>\n<p style=\"margin-left:.25in;\">\n 5.� � � Female subjects who have menarche must test negative for pregnancy at Screening and must consent to avoid becoming pregnant by using an approved contraception method throughout the study.</p>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion Criteria:</strong></p>\n<p>\n Subjects who meet any of the following criteria will be disqualified from entering the study:</p>\n<p style=\"margin-left:.25in;\">\n 1.� � � Subjects with active bleeding or high risk of bleeding contraindicating treatment with LMWH, SP Xa inhibitors, VKAs, or direct oral anticoagulants (DOACs; identified high risk of bleeding during prior experimental administration of DOACs).</p>\n<p style=\"margin-left:.25in;\">\n 2.� � � Subjects who have been or are being treated with thrombolytic agents, thrombectomy or insertion of a caval filter for the newly identified index VTE.</p>\n<p style=\"margin-left:.25in;\">\n 3.� � � Administration of antiplatelet therapy is contraindicated in both arms except for low dose aspirin defined as 1-5 mg/Kg/day with maximum of 100 mg/day (see Appendix 17.3.1).</p>\n<p style=\"margin-left:.25in;\">\n 4.� � � Subjects with hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk (aPTT > 50 seconds or international normalized ratio [INR] > 2.0 not related to anticoagulation therapy) or ALT > 5 × the upper limit of normal (ULN) or total bilirubin > 2 × ULN with direct bilirubin > 20% of the total at Screening Visit.</p>\n<p style=\"margin-left:.25in;\">\n 5.� � � Subjects with glomerular filtration rate (GFR) < 30% of normal for age and size (see Appendix 17.6) as determined by the Schwartz formula.</p>\n<p style=\"margin-left:.25in;\">\n 6.� � � Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed > 99th percentile + 5 mmHg (see Appendix 17.7).</p>\n<p style=\"margin-left:.25in;\">\n 7.� � � Subject with thrombocytopenia < 50 × 109/L at Screening Visit. Subjects with a history of heparin induced thrombocytopenia may be enrolled in the study at the Investigator’s discretion.</p>\n<p style=\"margin-left:.25in;\">\n 8.� � � Life expectancy less than the expected study treatment duration (3 months).</p>\n<p style=\"margin-left:.25in;\">\n 9.� � � Subjects who are known to be pregnant or breastfeeding.</p>\n<p style=\"margin-left:.25in;\">\n 10. Subjects with any condition that, as judged by the Investigator, would place the subject at increased risk of harm if he/she participated in the study.</p>\n
      • primary_end_points<p>\n <strong>Study Endpoints: </strong></p>\n<p>\n All safety and efficacy endpoints described below will be adjudicated in a blinded manner by the Clinical Events Committee (CEC).</p>\n<p>\n <strong>Primary Efficacy Endpoint:</strong></p>\n<p>\n The primary efficacy endpoint is a composite endpoint consisting of the incidence of symptomatic recurrent venous thromboembolic disease, death as a result of VTE, and no change or extension of thrombotic burden (Section 7.1) during the first 3 months period.</p>\n<p>\n <strong>Secondary Efficacy Endpoints:</strong></p>\n<p>\n The secondary efficacy endpoints include:</p>\n<p style=\"margin-left:.25in;\">\n ·ï¿½ � � � � � � � A composite endpoint consisting of symptomatic recurrent venous thromboembolic disease, death as a result of VTE, and no change or extension of thrombotic burden from randomization to the date of the last dose of study drug + 30 days .</p>\n<p style=\"margin-left:.25in;\">\n ·ï¿½ � � � � � � � The individual components of the primary efficacy endpoint during the first 3-month period:</p>\n<p style=\"margin-left:.75in;\">\n o� � Symptomatic recurrent VTE</p>\n<p style=\"margin-left:.75in;\">\n o� � Death as a result of VTE</p>\n<p style=\"margin-left:.75in;\">\n o� � No change or extension of thrombotic burden</p>\n<p style=\"margin-left:.25in;\">\n ·ï¿½ � � � � � � � All-cause mortality from randomization to last dose + 30 days.</p>\n<p style=\"margin-left:.25in;\">\n ·ï¿½ � � � � � � � The DVT, Catheter-related thrombosis, PE, sinovenous thrombosis events within and after the first 3-month treatment period.</p>\n<p>\n <strong>Net Clinical Outcome Endpoint:</strong></p>\n<p>\n Composite of symptomatic recurrent VTE events, death as a result of VTE, and major and CRNM bleeding that occurred from the date of the first dose of study drug to the date of last dose of study drug + 30 days.</p>\n<p>\n <strong>Safety Endpoints:</strong></p>\n<p>\n The safety endpoints are:</p>\n<p style=\"margin-left:.25in;\">\n ·ï¿½ � � � � � � � A combination of major and clinically relevant non- major (CRNM) bleedings occurring during treatment or within 3 days of completing or interrupting or stopping study during the first 3- month treatment period.</p>\n<p style=\"margin-left:.25in;\">\n ·ï¿½ � � � � � � � All bleedings from first to the last dose + 30 days.</p>\n<p style=\"margin-left:.25in;\">\n ·ï¿½ � � � � � � � A combination of major and CRNM bleedings from first to the last dose + 30 days.</p>\n<p>\n <strong>Pharmacokinetic and Pharmacodynamic Endpoints:</strong></p>\n<p>\n Will apply only in the 60 subjects in front-end multiple dose assessment</p>\n<p>\n <strong>Pharmacokinetics:</strong></p>\n<p>\n Using population PK analysis, the following PK parameters will be estimated: apparent systemic clearance (CL/F) and apparent volume of distribution (V/F) of edoxaban.</p>\n<p>\n <strong>Pharmacodynamics:</strong></p>\n<p>\n The following biomarkers of coagulation will be estimated: PT, aPTT, anti-FXa for edoxaban treatment arm</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic1
      • 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<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:648px;\" width=\"648\">\n <tbody>\n <tr>\n <td style=\"width:102px;\">\n <p align=\"center\">\n <strong>No of staff</strong></p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"center\">\n <strong>Name</strong></p>\n </td>\n <td style=\"width:276px;\">\n <p align=\"center\">\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:126px;\">\n <p align=\"center\">\n <strong>Experience</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:102px;\">\n <p align=\"center\">\n 1</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Bernhards Ogutu</p>\n </td>\n <td style=\"width:276px;\">\n <p>\n PhD (Clinical Pharmacology), (MMed) (Paediatrics), MBChB</p>\n <p>\n �</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Principal Investigator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:102px;\">\n <p align=\"center\">\n 1</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Jessie Githanga</p>\n </td>\n <td style=\"width:276px;\">\n <p>\n MBChB, MMed (Path)(UON), FCPath ECSA</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Co- Principal Investigator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:102px;\">\n <p align=\"center\">\n 1</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Anastacia Omoding</p>\n </td>\n <td style=\"width:276px;\">\n <p>\n � (MMed) (Paediatrics), MBChB, C.P.A 1 & 2</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Associate investigator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:102px;\">\n <p align=\"center\">\n 1</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Christine Jowi</p>\n </td>\n <td style=\"width:276px;\">\n <p>\n MB ChB M.Med (Paed)</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Cardiologist</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:102px;\">\n <p align=\"center\">\n 1</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Amina Salim</p>\n </td>\n <td style=\"width:276px;\">\n <p>\n Msc Clinical Trials, Dip. Clinical Medicine & Surgery</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Study coordinator</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:648px;\">\n <p align=\"center\">\n <strong>SITE FACILITIES</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:102px;height:64px;\">\n <p>\n 2 level five hospitals</p>\n </td>\n <td style=\"width:144px;height:64px;\">\n <p style=\"margin-left:.25in;\">\n 1.� � � � Mater Hospital</p>\n <p style=\"margin-left:.25in;\">\n 2.� � � � Gertrudes Hospital</p>\n </td>\n <td colspan=\"2\" style=\"width:402px;height:64px;\">\n <p>\n Dental facility,� � � Minor OT,� � � Physiotherapy, Laboratory services,� � � ECG Services, Pharmacy, X-Ray services, Ambulance Services, HDU,ICU, in patient services, outpatient services, Staff capacity, ward facilities</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n �</p>\n
      • other_details_explanation<p>\n This study is being conducted worldwide in different regions.</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:639px;\" width=\"639\">\n <thead>\n <tr>\n <th style=\"width:272px;height:47px;\">\n <p align=\"center\">\n <strong><u>Country</u></strong></p>\n </th>\n <th style=\"width:163px;height:47px;\">\n <p align=\"center\">\n <strong><u>Submission Status</u></strong></p>\n </th>\n <th style=\"width:205px;height:47px;\">\n <p align=\"center\">\n <strong><u>Regulatory Authority Decision and Date</u></strong></p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Brazil</p>\n <p>\n <strong><u>ANVISA - Agência Nacional de Vigilância Sanitária</u></strong></p>\n <p>\n SIA, Trecho 5, Área Especial 57, Bloco B, Térreo<br />\n Brasília -DF - CEP: 71205-050� - Brasil</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 21 Dec 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Croatia</p>\n <p>\n <strong><u>Ministry of Health</u></strong></p>\n <p>\n Ksaver 200a</p>\n <p>\n 10 000 Zagreb</p>\n <p>\n �</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 23 Dec 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Denmark</p>\n <p>\n <strong><u>Danish Data Protection Agency</u></strong></p>\n <p>\n <strong><u>Datatilsynet</u></strong><br />\n Borgergade 28, 5.<br />\n DK-1300 Copenhagen K.</p>\n <p>\n �</p>\n <p>\n <strong><u>Danish Health Authority</u></strong></p>\n <p>\n Islands Brygge 67<br />\n 2300 Copenhagen S</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 22 Dec 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Egypt</p>\n <p>\n <strong><u>Egyptian Ministry of Health-Central Administration for Research and Health Development (CCRHD)</u></strong></p>\n <p>\n 3 Magles El Shaab Street, Garden City,Cairo</p>\n <p>\n �</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 20 Sep 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Germany</p>\n <p>\n <strong><u>Bundesinstitut für Arzneimittel und Medizinprodukte</u></strong><br />\n Kurt-Georg-Kiesinger-Allee 3<br />\n 53175 Bonn</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 13 Sep 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Malaysia</p>\n <p>\n <strong><u>National Pharmaceutical Control Bureau</u></strong></p>\n <p>\n Lot 36, Jalan Universiti</p>\n <p>\n 46200 Petaling Jaya,</p>\n <p>\n Selangor, Malaysia</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 13 Jan 2017</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Romania</p>\n <p>\n <strong><u>Ministerul Sanatatii</u></strong></p>\n <p>\n Agentia Nationala a Medicamentului si a Dispozitivelor Medicale</p>\n <p>\n Str. Aviator Sanatescu 48, Sector 1, 011478, Bucuresti</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 21 Sep 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Serbia</p>\n <p>\n <strong><u>Medicines and Medical Devices Agency of Serbia </u></strong></p>\n <p>\n Vojvode Stepe 458, 11</p>\n <p>\n 152 Belgrade</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 8 Dec 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Slovenia</p>\n <p>\n <strong><u>Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices </u></strong></p>\n <p>\n Slovenčeva ulica 22</p>\n <p>\n SI-1000 Ljubljana</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 31 Oct 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Ukraine</p>\n <p>\n <strong><u>Ministry of Health of Ukraine</u></strong></p>\n <p>\n 7 Hrushevskoho str.</p>\n <p>\n Kyiv, 01601</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 20 Oct 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n �</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n �</p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:639px;\" width=\"639\">\n <thead>\n <tr>\n <th style=\"width:272px;height:47px;\">\n <p align=\"center\">\n <strong><u>Country</u></strong></p>\n </th>\n <th style=\"width:163px;height:47px;\">\n <p align=\"center\">\n <strong><u>Submission Status</u></strong></p>\n </th>\n <th style=\"width:205px;height:47px;\">\n <p align=\"center\">\n <strong><u>Regulatory Authority Decision and Date</u></strong></p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Canada</p>\n <p>\n <strong><u>Health Canada</u></strong><br />\n Address Locator 0900C2<br />\n Ottawa, Ontario<br />\n K1A 0K9</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 9 Sep 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p>\n Approved – 12 Oct 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Czech Republic</p>\n <p>\n <strong><u>Státní ústav pro kontrolu léčiv</u></strong></p>\n <p>\n � robárova 48</p>\n <p>\n 100 41 Praha 10</p>\n <p>\n Czech Republic</p>\n <p>\n �</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 14 Jul 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 15 Nov 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n France</p>\n <p>\n <strong><u>ANSM: Agence Nationale de Sécurité du Médicament et des produits de santé</u></strong><br />\n 143/147, boulevard Anatole France<br />\n 93285 SAINT-DENIS CEDEX</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 30 Aug 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 28 Oct 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Hungary</p>\n <p>\n <strong><u>Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI)/ National Institute of Pharmacy and Nutrition</u></strong></p>\n <p>\n 1051 Budapest, Zrínyi utca 3.</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 15-Aug-16</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 25 Oct 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Israel</p>\n <p>\n <strong><u>Ministry of Health</u></strong></p>\n <p>\n 39 Yermiyahu st, Jerusalem</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 30-Jun-16</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 20 Dec 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Korea, Republic of</p>\n <p>\n <strong><u>Ministry of Food and Drug Safety (MFDS)</u></strong></p>\n <p>\n 187 Osongsaengmyeong-2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28159, South Korea</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 29 Jun 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 11 Oct 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Netherlands</p>\n <p>\n <strong><u>Central Committee on Research Involving Human Subjects (CCMO)</u></strong></p>\n <p>\n Parnassusplein 5</p>\n <p>\n 2511 VX The Hague</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 21 Dec 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 6 Jan 2017</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Portugal</p>\n <p>\n <strong><u>INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, IP</u></strong></p>\n <p>\n Parque de Saúde de Lisboa - Avenida do Brasil, 53<br />\n 1749-004 Lisboa</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 29 Jul 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 19 Dec 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Russia</p>\n <p>\n <strong><u>Ethical Council</u></strong></p>\n <p>\n <strong><u>Ministry of Health of Russian Federation</u></strong></p>\n <p>\n 127 994, Moscow, Rakhmanovsky lane, 3</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 29 Jul 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 30 Nov 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Singapore</p>\n <p>\n <strong><u>Health Sciences Authority</u></strong></p>\n <p>\n 11 Biopolis Way</p>\n <p>\n #11-01, Helios</p>\n <p>\n Singapore 138667</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 6 Aug 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 21 Sep 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Spain</p>\n <p>\n <strong><u>Ag</u></strong><a href=\"http://www.aemps.gob.es/\"><strong>encia Española de Medicamentos y Productos Sanitarios</strong></a><br />\n Parque Empresarial Las Mercedes</p>\n <p>\n Edificio 8, Calle Campezo 1</p>\n <p>\n 28022 Madrid</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 13 Sep 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 27 Oct 2016</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Turkey</p>\n <p>\n <strong><u>Turkish Medicine and Medical Device Agency</u></strong></p>\n <p>\n Sogutozu Mahallesi 2176 Sokak No:5 �</p>\n <p>\n 06520 Cankaya Ankara</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 28 Sep 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Approved 11 Jan 2017</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n United States</p>\n <p>\n <strong><u>Food and Drug Administration</u></strong><br />\n 10903 New Hampshire Ave<br />\n Silver Spring, MD 20993-0002</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 15 Aug 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Tacit approval – 15 Sep 2016</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n �</p>\n
      • other_details_regulatory_rejected<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:639px;\" width=\"639\">\n <thead>\n <tr>\n <th style=\"width:272px;height:47px;\">\n <p align=\"center\">\n <strong><u>Country</u></strong></p>\n </th>\n <th style=\"width:163px;height:47px;\">\n <p align=\"center\">\n <strong><u>Submission Status</u></strong></p>\n </th>\n <th style=\"width:205px;height:47px;\">\n <p align=\"center\">\n <strong><u>Regulatory Authority Decision and Date</u></strong></p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width:272px;height:50px;\">\n <p>\n Italy</p>\n <p>\n <strong><u>AIFA</u></strong></p>\n <p>\n Ufficio Ricerca e Sperimentazione Clinica</p>\n <p>\n Via del Tritone, 181</p>\n <p>\n 00187 Rome</p>\n </td>\n <td style=\"width:163px;height:50px;\">\n <p align=\"center\">\n Submitted 22 Sep 2016</p>\n </td>\n <td style=\"width:205px;height:50px;\">\n <p align=\"center\">\n Denied 9 Dec 2016</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n �</p>\n
      • other_details_regulatory_halted
      • estimated_duration4.5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard of care (SOC; in
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyStandard of care (SOC; including low Molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors)
      • 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_states32
      • number_of_sites2
      • multi_country_listArgentina, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Kenya, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Thailand, Turkey, Ukraine, United States
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwide274
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • 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_nameBernhards Ogutu
      • investigator1_middle_name
      • investigator1_family_nameRagama
      • investigator1_qualificationPhD (Clinical Pharmacology), MMed (Paediatrics), MBChB
      • investigator1_professional_addressCentre for Research in Therapeutic Sciences, Strathmore University, P.O Box 59857-0020
      • investigator1_telephone+254733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants10
      • notification<p>\n please find attached ;</p>\n<p>\n  </p>\n<ul>\n <li>\n Independent Data Monitoring Committee Report for Data Review meeting # 10</li>\n <li>\n cover letter dated 6th march 2020</li>\n</ul>\n
      • approval_date03-10-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-05-2020
      • 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)
      • modified2021-03-25 10:00:02
      • created2017-03-16 12:34:46
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id381
        • application_id601
        • given_nameBernhards Ragama
        • middle_nameOgutu
        • family_nameRagama
        • qualificationPhD (Clinical Pharmacology), (MMed) (Paediatrics), MBChB
        • professional_addressCentre for Research in Therapeutic Sciences, Strathmore University (CREATES,SU), P.O BOX 59857-00200, Nairobi
        • telephone+254 733 812613
        • emailogutu6@gmail.com
        • created2017-03-16 12:49:04
        • modified2020-05-04 12:03:13
    • SiteDetail(array)
      • 0(array)
        • id480
        • application_id601
        • county_id47
        • site_nameGertrudes Hospital
        • physical_address Muthaiga Rd, Nairobi, Kenya
        • contact_detailsP. O. Box 42325 Muthaiga Rd, Nairobi, Kenya
        • contact_personTruphena Otinyo
        • site_capacity(null)
        • misc(null)
        • created2017-03-16 12:49:04
        • modified2020-05-04 12:03:13
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id481
        • application_id601
        • county_id47
        • site_nameMater Hospital
        • physical_addressalong Dunga Road, South B, Nairobi.
        • contact_detailsalong Dunga Road, South B, Nairobi. Telephone: +254 (20) 690 3000
        • contact_personMedical Director
        • site_capacity(null)
        • misc(null)
        • created2017-03-17 11:13:04
        • modified2020-05-04 12:03:13
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id305
        • application_id601
        • sponsorDaiichi Sankyo, Inc. 399 Thornall Street Edison, NJ 08837
        • sponsor_typeIndustry
        • contact_personRika Pieterse
        • addressMontrose Place 2 Bella Rosa Street Rosenpark, Bellville Cape Town, South Africa 7530
        • telephone_numberOffice: +27 21 9175823
        • fax_number
        • cell_numberMobile: +27 83 6520915
        • email_addressrika.pieterse@iqvia.com
        • created2017-03-16 12:49:04
        • modified2020-05-04 12:03:13
  • 2(array)
    • Application(array)
      • id593
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n The World Health Organization recommends daily oral PrEP containing tenofovir for the prevention of HIV infection in persons at substantial HIV risk. Open label PrEP studies have demonstratedvery high uptake, adherence, and effectiveness of oral PrEP in heterosexual African HIV serodiscordant couples and men who have sex with men in the Americas and Europe. The first open-label study of oral PrEP among young women in a township near Cape Town, South Africa also demonstrated high adherence. However, PrEP has not been delivered to women in many African settings, and effective delivery models for PrEP are needed. Young African women are an important population for PrEP implementation, with one of the highest annual HIV incidence rates globally, even in recent HIV prevention trials which provided the best available standard of prevention services (condoms, STI services, and counseling). Women between the ages of 16 and 24represent three of the four million young people living with HIV in Africa. Given the high HIV incidence and evidence for high effectiveness of PrEP when adherence to product use is high, PrEP delivery, uptake and adherence need to be evaluated among young African women.The impact will be greatest if the subset of young women who are at highest risk of HIV infection are motivated to use PrEP and are able to establish daily pill-taking habits and sustain high adherence while they remain at risk. This protocol describes an implementation science study of PrEP delivery to young women in South Africa and Kenya. Oral PrEP delivery has been defined as an emerging part of standard of care (SOC) for HIV prevention in Kenya and South Africa. Both Kenya and South Africa regulatory authorities have approved an indication for PrEP for the combination medication tenofovir disoproxil fumarate / emtricitabine (TDF/FTC), based on clinical safety and efficacy data.Onto HIV SOC that includes PrEP, we propose to conduct an open cohort study to evaluate oral PrEP uptake and use as well as delivery efficiency. The prospective cohort study will enroll sexually active HIV negative women ages 16-25 in Cape Town, South Africa, Kisumu, Kenya, and Johannesburg, South Africa. Uptake of and adherence to PrEP, when presented as a SOC option, will be assessed, as will the delivery of the SOC PrEPpackage itself.</p>\n
      • study_title<p>\n A cohort for evaluation of open-label PrEP delivery among Kenyan and South African women</p>\n
      • laymans_summary<p>\n In 2015 the WHO recommendedtaking daily oral PrEP containing ARV based medication used for treatment of HIV for the prevention of HIVin individuals at considerable HIV risk. Demonstration PrEP studies showed very high use, adherence, and successof PrEP medication taken by couples in HIV serodiscordant relationships;men who have sex with men in the Americas and Europe.Kenya last year launched the national Guidelines on Use of PrEP for preventing HIV infection. PrEP is safe and effective and is registered for use by the Pharmacy and Poisons Board in Kenya.Despite these milestones, PrEP is not widely available to young women in part due to policymaker’s need for delivery strategies that effectively reach those at highest risk of HIV, Therefore, effective delivery models for PrEP are needed to determine PrEP use and adherence in these young women who are at highest risk of HIV infection and are motivated to take PrEP, sustain high adherence so long as they remain at risk.</p>\n
      • short_titleThe POWER cohort
      • protocol_noECCT/17/03/01
      • version_noVersion 1.1
      • date_of_protocol13-10-2017
      • study_drugTenofovir disoproxil fumarate / emtricitabine (TDF/FTC),
      • disease_conditionHIV/AIDS
      • 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_nameTruvada
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaachoka@kemri-ucsf.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProf. ElizabethBukusi, P.O Box 614-40100 Kisumu
      • declaration_date101-03-2017
      • declaration_principal_investigatorProf. ElizabethBukusi, P.O Box 614-40100 Kisumu
      • declaration_date201-03-2017
      • placebo_presentNo
      • study_objectives<p>\n 1. Assess the characteristics of women who initiate PrEP during follow-up versus do not initiate PrEP.</p>\n<p>\n 2. Determine the persistence and patterns of PrEP use as they relate to contraceptive use, pregnancy and sexual exposure, and timing and reasons for PrEP discontinuation.</p>\n<p>\n 3. Assess HIV incidence in relationship to PrEP use, and HIV drug resistance among seroconverters on PrEP.</p>\n<p>\n 4. Demonstrate PrEP delivery models for young women in family planning setting in Kisumu.</p>\n<p>\n 5. Assess cost, and cost-effectiveness of PrEP when delivered in public health clinics.</p>\n
      • principal_inclusion_criteria<p>\n - Age 16-25 o 16 and 17 year olds, where permissible by national regulations and local IRB approval -</p>\n<p>\n Able and willing to provide written informed consent -</p>\n<p>\n Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months) -</p>\n<p>\n HIV uninfected based on negative HIV rapid tests, on the date of enrollment</p>\n
      • principal_exclusion_criteria<p>\n HIV infected women</p>\n<p>\n Not willing to provide consent</p>\n<p>\n Not sexually active</p>\n
      • primary_end_points<p>\n seroconversion</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAdherence monitoring
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Elizabeth Bukusi, MBChB, MMed, MPH, PhD, Principal Investigator</p>\n<p>\n Josephine Odoyo, KRCHN/MCHD</p>\n<p>\n Dr Zachary Kwena , BA, MA , PHD,</p>\n<p>\n Dr Stella Njuguna , B Pharm, MPH</p>\n
      • other_details_explanation<p>\n High risk population in kenya</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n University of Washington IRB</p>\n<p>\n Kenya Medical Research Institute.</p>\n<p>\n <br />\n  </p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationUpto 36 Months
      • 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites2
      • multi_country_listKENYA AND SOUTH AFRICA
      • data_monitoring_committeeYes
      • total_enrolment_per_site500
      • total_participants_worldwide3000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • 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, MMed, MPH, PhD
      • investigator1_professional_addressP.O BOX 614-40100 Kisumu
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@gmail.com
      • organisations_transferred_No
      • number_participants1000
      • notification
      • approval_date04-05-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-06-2020
      • 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)
      • modified2021-12-23 11:17:11
      • created2017-02-27 16:17:05
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id377
        • application_id593
        • given_nameDr. Stella
        • middle_name
        • family_nameNjuguna
        • qualificationB.Pharm/MPH
        • professional_addressP.O BOX 614-40100 Kisumu
        • telephone+254 722422977
        • emailnjugunastella@gmail.com
        • created2017-02-27 16:51:44
        • modified2020-06-30 11:08:28
    • SiteDetail(array)
      • 0(array)
        • id474
        • application_id593
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital.
        • physical_addressKisumu-Kakamega Road
        • contact_detailsP.O Box 614-40100 KISUMU
        • contact_personMerceline Awuor
        • site_capacity(null)
        • misc(null)
        • created2017-02-27 16:51:44
        • modified2020-06-30 11:08:28
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id303
        • application_id593
        • sponsorUnited States Agency for International Development
        • sponsor_typeOthers
        • contact_personJared B
        • addressP.O BOX 359470
        • telephone_number206-543-0098
        • fax_number206-543-9218
        • cell_number206-520-3831
        • email_addressCWSCOV@UW.edu
        • created2017-02-27 16:51:44
        • modified2020-06-30 11:08:28
  • 3(array)
    • Application(array)
      • id574
      • user_id73
      • trial_status_id8
      • abstract_of_study<p>\n The World Health Organization recommends ART at any CD4 count for persons with HIV-1 infection, particularly those with HIV-1 uninfected partners, and PrEP for persons at high risk of HIV-1 acquisition.  The Kenya Ministry of Health has developed an ambitious HIV Prevention Revolution Road Map 2030, including provision of ART regardless of CD4 count and PrEP for HIV-1 serodiscordant couples. In July 2016, the Ministry of Health in Kenya released “Guidelines on use of Antiretroviral Drugs for Treating and Preventing HIV infections in Kenya” which recommend initiation of ART for all HIV infected persons irrespective of CD4 count and oral PrEP for HIV-1 uninfected persons with substantial ongoing risk of HIV infection, including HIV discordant couples. Nevertheless, delivery approaches that will catalyze scale-up of PrEP and ART have not been implemented.  HIV-1 care in Kenya is principally delivered through public health HIV-1 care centers, thus offering an existing platform for incorporating clinical prevention services for couples.  This project will scale-up integrated PrEP and ART for HIV-1 serodiscordant couples in Kenya to HIV-1 care centers in several counties in Kenya, including 12 in Central Kenya (former central and Nairobi province).  It will include a delivery component in which PrEP will be delivered according to Kenyan national guidelines, utilizing the integrated PrEP as a bridge to ART approach. We will conduct monitoring and evaluation activities to identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up.  A research component will establish prospective open cohorts of couples at each clinic, who will be offered PrEP and ART according to Kenyan national guidelines; follow-up in the cohorts will evaluate impact and facilitators and barriers to implementation at levels from the patient to the health system. </p>\n<p>\n <strong>Design:  </strong>Prospective, open-label cohort study at HIV-1 care centers in Kenya including 12 in central Kenya.  The PrEP as a bridge to ART intervention will be introduced into clinics according to national guidelines in a staged fashion, stratified by clinic size & region (a stepped wedge design).  Follow-up will be for up to 36 months at each care center.</p>\n<p>\n <strong>Population:   </strong>Heterosexual HIV-1 serodiscordant couples, ≥18 years of age, mutually disclosed.  Up to 200 couples per clinic will participate in the prospective open cohort research evaluation.  Up to 200 key delivery informants will participate in qualitative interviews about PrEP delivery.</p>\n
      • study_title<p align=\"center\" class=\"MediumGrid21\" style=\"text-align:center;line-height:200%\">\n <b><span style=\"font-family:"Arial",sans-serif\">An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention </span></b><b style=\"line-height: 200%;\"><span style=\"font-family:"Arial",sans-serif\">among Kenyan HIV-1 serodiscordant couples</span></b></p>\n
      • laymans_summary<p>\n Antiretroviral-based HIV-1 prevention strategies – including antiretroviral treatment (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons to prevent HIV-1 acquisition – are among the most promising new approaches for dramatically decreasing HIV-1 spread worldwide. A priority population for implementation of ART and PrEP for HIV-1 prevention is HIV-1 serodiscordant couples (i.e., one member is HIV-1 infected and the other uninfected).  In Kenya, heterosexual HIV-1 serodiscordant couples face high risk of HIV-1 transmission and account for a substantial fraction of new infections.  Over the past decade, randomized trials and other clinical investigations have definitively demonstrated that both ART and PrEP have high HIV-1 protection efficacy when used by members of HIV-1 serodiscordant couples.  A pragmatic, integrated approach to providing ART and PrEP, with ART promoted for the HIV-1 infected partner in all couples and PrEP offered until six months after ART initiation by the HIV-1 infected partner to permit time to achieve virologic suppression (a strategy called “PrEP as a bridge to ART”), resulted in near-elimination of HIV-1 transmission in a demonstration project among HIV-1 serodiscordant couples.  </p>\n
      • short_title The Partners Scale-Up Project
      • protocol_noECCT/16/12/03
      • version_no1.0
      • date_of_protocol24-10-2016
      • study_drugEmtricitabine/Tenofovir Disoproxil Fumarate (Truvada) - Scale-Up Project
      • disease_conditionPrEP for HIV Prevention in Discordant Couples
      • 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_nameEmtricitabine/Tenofovir Disoproxil Fumarate (Truvada)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@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_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • 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_budget0
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Elizabeth Irungu
      • declaration_date106-12-2016
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date206-12-2016
      • placebo_presentNo
      • study_objectives<p style=\"margin-left:1in;\">\n <strong>Objective 1:   Deliver integrated PrEP and ART for HIV-1 serodiscordant couples at scale in public HIV-1 care centers in Kenya and evaluate program impact.  </strong>We will introduce the PrEP as a bridge to ART strategy into public HIV-1 care centers according to national guidelines, and we will rigorously evaluate how effectively this strategy is disseminated and implemented.  Key endpoints will include: a) proportion of HIV-1 infected persons whose partners are tested for HIV-1, b) rates of PrEP initiation, adherence, and discontinuation by HIV-1 uninfected partners until their HIV-1 infected partners initiate ART and sustain use for six months, c) ART initiation and adherence by HIV-1 infected individuals, d) couples achieving optimized antiretroviral-based prevention coverage (i.e., high adherence to at least one antiretroviral intervention), and e) HIV-1 uninfected partners staying HIV-1 uninfected.  <em>Note:</em> <em>Both ART and PrEP have regulatory and normative guidance sanction in Kenya and are not investigational agents.  Thus, the research components of this Objective will focus on optimizing their delivery, rather than on research related to the medications themselves. </em></p>\n<p style=\"margin-left:45pt;\">\n  </p>\n<p style=\"margin-left:1in;\">\n <strong>Objective 2:   Assess facilitators and barriers to a) implementation of integrated PrEP and ART in delivery settings and b) optimized PrEP and ART adherence.  </strong>In parallel with Objective 1, we will conduct mixed-methods assessments of a) PrEP and ART integration at the level of the provider, health center, and health system and b) adherence at the levels of individuals and dyads. We will use this data iteratively to optimize implementation. Adherence to PrEP and ART will be quantified.  </p>\n<p style=\"margin-left:45pt;\">\n  </p>\n<p style=\"margin-left:1in;\">\n <strong>Objective 3:   Determine efficiency, cost, and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.  </strong>We will conduct time and motion studies to optimize delivery efficiency, define the costs, and model the cost-effectiveness of PrEP as a bridge to ART, in terms of infections averted, disability-adjusted life years saved, and incremental cost-effectiveness over routine HIV-1 care.</p>\n<p style=\"margin-left:1in;\">\n  </p>\n<p style=\"margin-left:1in;\">\n <strong>Objective 4:   Develop operational tools that will expand and support delivery of integrated PrEP and ART at scale and secure buy in from relevant stakeholders to ensure delivery continues to scale up at the national level.</strong> As part of the Objective 1 delivery work, and refined through information learned in Objectives 2 and 3, we will develop training materials, clinical delivery products, and assessment tools.  We will also coordinate with program and policy stakeholders to optimize supply chain management, commodities, and training regarding PrEP in Kenya. Finally, we will work with government, civil society, clinical providers and community to provide the necessary foundation to further expand integrated delivery of PrEP and ART at a wider scale in Kenya. </p>\n
      • principal_inclusion_criteria<p>\n <em>Eligibility</em></p>\n<p>\n  </p>\n<p>\n For HIV-1 uninfected members of the couple</p>\n<p style=\"margin-left:.75in;\">\n -       Age ≥18</p>\n<p style=\"margin-left:.75in;\">\n -       Able and willing to provide consent for follow-up in the cohort</p>\n<p style=\"margin-left:1.0in;\">\n -       HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines</p>\n<p style=\"margin-left:.75in;\">\n -       Not currently using PrEP</p>\n<p>\n  </p>\n<p>\n For HIV-1 infected members of the couple</p>\n<p style=\"margin-left:.75in;\">\n -       Age ≥18</p>\n<p style=\"margin-left:.75in;\">\n -       Able and willing to provide consent for follow-up in the cohort</p>\n<p style=\"margin-left:.75in;\">\n -       HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines</p>\n<p>\n For both members of the couple</p>\n<p style=\"margin-left:.5in;\">\n -       Meet criteria for initiating PrEP as per Kenya national guidelines, including:</p>\n<p style=\"margin-left:1.0in;\">\n o   HIV-1 infected member not currently using ART, on ART <6 months, or on ART but not virally suppressed based on a viral load test done at the clinic as per Kenya national guidelines or</p>\n<p style=\"margin-left:1.0in;\">\n o   Trying to conceive</p>\n<p>\n For key delivery informants</p>\n<p style=\"margin-left:.75in;\">\n -       Able and willing to provide consent </p>\n
      • principal_exclusion_criteria<p>\n For both members of the couple:</p>\n<ul>\n <li>\n Unable or unwilling to provide consent for follow up in cohort.</li>\n <li>\n HIV status not mutually disclosed.</li>\n</ul>\n
      • primary_end_points<p>\n a) proportion of HIV-1 infected persons whose partners are tested for HIV-1,</p>\n<p>\n b) rates of PrEP initiation, adherence, and discontinuation by HIV-1 uninfected partners until their HIV-1 infected partners initiate ART and sustain use for six months, c) ART initiation and adherence by HIV-1 infected individuals,</p>\n<p>\n d) couples achieving optimized antiretroviral-based prevention coverage (i.e., high adherence to at least one antiretroviral intervention), and</p>\n<p>\n e) HIV-1 uninfected partners staying HIV-1 uninfected.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Partners in Health & Research Development (Formerly Partners in Prevention), has 38 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists, social scientists ).</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Nelly R. Mugo  MBCHB,MMED,MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Co-Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Country Lead: Dr. Elizabeth Irungu  MBCHB, MPH</p>\n
      • other_details_explanation<p>\n Antiretroviral-based HIV-1 prevention strategies – including antiretroviral treatment (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons to prevent HIV-1 acquisition – are among the most promising new approaches for dramatically decreasing HIV-1 spread worldwide. A priority population for implementation of ART and PrEP for HIV-1 prevention is HIV-1 serodiscordant couples. In Kenya, heterosexual HIV-1 serodiscordant couples face high risk of HIV-1 transmission and account for a substantial fraction of new infections.   Over the past decade, randomized trials and other clinical investigations have definitively demonstrated that both ART and PrEP have high HIV-1 protection efficacy when used by members of HIV-1 serodiscordant couples.  A pragmatic, integrated approach to providing ART and PrEP, with ART promoted for the HIV-1 infected partner in all couples and PrEP offered until six months after ART initiation by the HIV-1 infected partner to permit time to achieve virologic suppression (a strategy called “PrEP as a bridge to ART”), resulted in near-elimination of HIV-1 transmission in a demonstration project among HIV-1 serodiscordant couples.</p>\n<p>\n The World Health Organization recommends ART at any CD4 count for persons with HIV-1 infection, particularly those with HIV-1 uninfected partners, and PrEP for persons at high risk of HIV-1 acquisition.   The Kenya Ministry of Health has developed an ambitious HIV Prevention Revolution Road Map 2030, including provision of ART regardless of CD4 count and PrEP for HIV-1 serodiscordant couples. In July 2016, the Ministry of Health in Kenya released  “Guidelines  on  use  of  Antiretroviral  Drugs  for  Treating  and  Preventing  HIV infections in Kenya” which recommend initiation of ART for all HIV infected persons irrespective of CD4 count and oral PrEP for HIV-1 uninfected persons with substantial ongoing risk of HIV infection, including HIV discordant couples. Nevertheless, delivery approaches that will catalyze scale-up of PrEP and ART have not been implemented.  HIV-1 care in Kenya is principally delivered through public health HIV-1 care centers, thus offering an existing platform for incorporating clinical prevention services for couples.   This project will scale-up integrated PrEP and ART for HIV-1 serodiscordant couples in Kenya to HIV-1 care centers in several counties in Kenya, including 12 in Central Kenya (former central and Nairobi province).  It will include a delivery component in which PrEP will be delivered according to Kenyan national guidelines, utilizing the integrated PrEP as a bridge to ART approach. </p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI's SERU - 24th November 2016</p>\n<p>\n University of Washington's IRB - 24th May 2016</p>\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_duration5 years
      • 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites12 (Nairobi & Central parts of Kenya)
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site200
      • total_participants_worldwide4800
      • 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_male1
      • subjects_healthyYes
      • 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_nameJared
      • investigator1_middle_nameMurray
      • investigator1_family_nameBaeten
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressUniversity of Washington, Box 359927; 325 Ninth Avenue, Seattle Washington 98104
      • investigator1_telephone206 520 3808
      • investigator1_emailjbaeten@uw.edu
      • organisations_transferred_Yes
      • number_participants2400 (Nairobi and Central parts of Kenya)
      • notification
      • approval_date04-02-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-02-2020
      • is_child0
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      • approved2
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      • final_date(null)
      • modified2021-09-09 12:06:20
      • created2016-12-01 11:27:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id371
        • application_id574
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MMeD, MPH
        • professional_address19865-00202
        • telephone067-22561, 0723914057
        • emailrwamba@csrtkenya.org
        • created2016-12-02 08:55:08
        • modified2020-02-13 21:47:29
    • SiteDetail(array)
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        • site_nameThika Level 5 Hospital, Ruiru Sub-County Hospital, Kiambu County Hospital, Kikuyu PCEA Hospital
        • physical_addressThika Sub-County, Ruiru, Kiambu, Kikuyu township
        • contact_detailsKiambu
        • contact_personCCC Manager
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        • created2016-12-02 08:55:08
        • modified2020-02-13 21:47:29
        • County(array)
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          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 1(array)
        • id456
        • application_id574
        • county_id47
        • site_nameCoptic Hospital, Mbagathi Hospital, St. Mary\'s Hospital, Pumwani Maternity Hospital
        • physical_addressNgong Road, Off Mbagathi road, Lang\'ata, Carlifonia Eastleigh - Nairobi
        • contact_detailsNairobi
        • contact_personCCC Manager
        • site_capacity(null)
        • misc(null)
        • created2016-12-02 15:25:45
        • modified2020-02-13 21:47:29
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
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      • 2(array)
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        • site_nameNyeri PGH, Karatina Sub-County Hospital,
        • physical_addressNyeri, Karatina
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        • contact_personCCC Manager
        • site_capacity(null)
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        • created2016-12-02 16:30:21
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        • County(array)
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          • county_nameNyeri
          • created2012-06-15 10:24:16
          • modified2012-06-15 10:24:16
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        • id466
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        • site_nameKerugoya County Hospital
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        • contact_detailsKirinyaga
        • contact_personCCC Manager
        • site_capacity(null)
        • misc(null)
        • created2016-12-02 16:36:21
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        • County(array)
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          • county_nameKirinyaga
          • created2012-06-15 10:24:22
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        • id467
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        • site_nameMurang\'a County Hospital
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        • contact_detailsMurang\'a
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        • misc(null)
        • created2016-12-02 16:37:20
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        • County(array)
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          • created2012-06-15 10:24:31
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        • id297
        • application_id574
        • sponsorUniversity of Washington
        • sponsor_typeResearch Institution
        • contact_personDr. Nelly R. Mugo
        • address19865-00202
        • telephone_number0672222561
        • fax_numbern/a
        • cell_number0733629665
        • email_addressrwamba@csrtkenya.org
        • created2016-12-02 08:55:08
        • modified2020-02-13 21:47:29
  • 4(array)
    • Application(array)
      • id577
      • user_id613
      • trial_status_id8
      • abstract_of_study<p>\n Tuberculosis (TB) is one of the most important global health problems. According to recent estimates from the World Health Organization (WHO), 8.6 million new cases and 1.3 million deaths from TB occurred in 2012. The vast majority of TB cases and TB deaths are in developing countries. The spread of HIV has fuelled the TB epidemic, and TB is the leading cause of death among patients infected with HIV. The national case notification rate is 217/100 000, whilst in Kericho County, the rate is 246 /100 000. TB treatment takes 6 months in Kenya and this relatively long treatment is associated with relatively poor compliance and high relapse rates than if the regimen were shorter. This contributes to increase in patient morbidity and mortality, Mycobacterium tuberculosis transmission and drug resistant TB. Treatment adherence is critical in TB treatment success and a shorter regimen may improve adherence. This highlights the need to shorten further the duration of TB treatment. This study aims to evaluate the efficacy, safety and tolerability of 2 treatment regimens versus the standard drug susceptible TB treatment regimen currently used in Kenya. Male or female participants who are 12 years or older with smear positive pulmonary TB will be enrolled and randomized into either 8 weeks of Rifampicin, Isoniazid, Pyrazinamide, Ethambutol followed by 18 weeks of Rifampicin and Isoniazid or 8 weeks of Rifapentine, Isoniazid, Pyrazinamide, Ethambutol followed by 9 weeks of Rifapentine and Isoniazid or 8 weeks of Rifapentine, Isoniazid, Pyrazinamide, Moxifloxacin followed by 9 weeks of Rifapentine, Isoniazid and Moxifloxacin. The Kericho site will recruit 80-100 participants and follow them up for 18 months. If shorter TB treatment regimen is efficacious compared to current 6 month TB treatment duration, this will potentially have important public health implications by increasing TB cure rates, potentially reducing TB transmission and preventing emergency of MDR TB.</p>\n
      • study_title<p>\n Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial.</p>\n
      • laymans_summary<p>\n Tuberculosis (TB) is one of the most important global health problems. According to recent estimates from the World Health Organization (WHO), 8.6 million new cases and 1.3 million deaths from TB occurred in 2012. The vast majority of TB cases and TB deaths are in developing countries. The spread of HIV has fuelled the TB epidemic, and TB is the leading cause of death among patients infected with HIV. The national case notification rate is 217/100 000, whilst in Kericho County, the rate is 246 /100 000. TB treatment takes 6 months in Kenya and this relatively long treatment is associated with relatively poor compliance and high relapse rates than if the regimen were shorter. This contributes to increase in patient morbidity and mortality, Mycobacterium tuberculosis transmission and drug resistant TB. Treatment adherence is critical in TB treatment success and a shorter regimen may improve adherence. This highlights the need to shorten further the duration of TB treatment. This study aims to evaluate the efficacy, safety and tolerability of 2 treatment regimens versus the standard drug susceptible TB treatment regimen currently used in Kenya. Male or female participants who are 12 years or older with smear positive pulmonary TB will be enrolled and randomized into either 8 weeks of Rifampicin, Isoniazid, Pyrazinamide, Ethambutol followed by 18 weeks of Rifampicin and Isoniazid or 8 weeks of Rifapentine, Isoniazid, Pyrazinamide, Ethambutol followed by 9 weeks of Rifapentine and Isoniazid or 8 weeks of Rifapentine, Isoniazid, Pyrazinamide, Moxifloxacin followed by 9 weeks of Rifapentine, Isoniazid and Moxifloxacin. The Kericho site will recruit 80-100 participants and follow them up for 18 months. If shorter TB treatment regimen is efficacious compared to current 6 month TB treatment duration, this will potentially have important public health implications by increasing TB cure rates, potentially reducing TB transmission and preventing emergency of MDR TB.</p>\n
      • short_titleRifapentine-containing treatment shortening regimens for pulmonary tuberculosis:
      • protocol_noECCT/16/12/02
      • version_no2.0
      • date_of_protocol14-05-2015
      • study_drugRifapentine, Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide, Ethambutol
      • disease_conditionPulmonary Tuberculosis
      • 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_nameRifapentine, Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide, Ethambutol
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressisaac.tsikhutsu@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
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      • applicant_signed_declaration1
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      • applicant_detailed_budget1
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      • applicant_registration_ctr(null)
      • applicant_pan_african1
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantISAAC TSIKHUTSU, P.O. BOX 1357 KERICHO
      • declaration_date114-12-2016
      • declaration_principal_investigatorBEATRICE KORIR , P.O. BOX 1357 KERICHO
      • declaration_date214-12-2016
      • placebo_presentNo
      • study_objectives<h1>\n <strong>1.</strong><strong>OBJECTIVES</strong></h1>\n<h2>\n 1.1PRIMARY OBJECTIVE</h2>\n<p style=\"margin-left:63.35pt;\">\n 9.1.1 To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis.</p>\n<p style=\"margin-left:63.35pt;\">\n 9.1.2 To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis.</p>\n<p style=\"margin-left:63.0pt;\">\n  </p>\n<h2>\n 1.2SECONDARY OBJECTIVES</h2>\n<p style=\"margin-left:63.35pt;\">\n 9.2.1 To evaluate the safety of the investigational regimens.</p>\n<p style=\"margin-left:63.35pt;\">\n 9.2.2 To evaluate the tolerability of the investigational regimens.</p>\n<p style=\"margin-left:63.35pt;\">\n 9.2.3 To collect and assess biospecimens from consenting participants for the purpose of research on discovery and validation of TB biomarkers.</p>\n<p style=\"margin-left:63.35pt;\">\n 9.2.4 To determine the correlation of mycobacterial and clinical markers with time to culture conversion, culture status at completion of eight weeks of treatment, treatment failure, and relapse.</p>\n<p style=\"margin-left:63.35pt;\">\n 9.2.5 To conduct a pharmacokinetic/pharmacodynamic (PK/PD) study of the test drugs.  The main objectives of the PK/PD study are to characterize study drug PK parameters and to determine relationships between treatment outcomes and PK parameters.</p>\n<p style=\"margin-left:63.35pt;\">\n 9.2.6 To evaluate the pharmacokinetics of efavirenz-based antiretroviral treatment among patients with TB/HIV co-Infection taking efavirenz-based combination antiretroviral therapy and TB treatment with rifapentine.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing, with semiquantitative result of ‘medium’ or ‘high’ and rifamycin resistance not detected</p>\n
      • principal_exclusion_criteria<p>\n Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones. Screening, baseline, and Week 2 study visit sputum cultures all fail to grow M. tuberculosis. M. tuberculosis cultured or detected through molecular assays (Cepheid Xpert MTB/RIF or Hain MTBDRplus assays) from sputum obtained around the time of study entry is determined subsequently to be resistant to one or more of isoniazid, rifampin, or fluoroquinolones.</p>\n
      • primary_end_points<p>\n Primary Efficacy End Point: TB disease-free survival at twelve months after study treatment assignment. Primary Safety End Point: Proportion of participants with grade 3 or higher adverse events during study treatment.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • 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 Kericho CRC, established in 1998, is located 260 km Northwest of Nairobi in Kericho town on the grounds of the Ministry of Health, Kericho County Referral Hospital. USAMRU-K has been in Kenya for 45 years and has partnered with KEMRI since 1980. KEMRI is a Government of Kenya para-state corporation responsible for health research. The CRC has three integrated main components: HIV care, HIV and microbiology research. Since 2003 the CRS has been conducting diverse studies including randomized, double-blind, placebo controlled and IND/FDA-regulated studies The CRS has 181 local and one U.S. staff with appropriate trainings to support the clinical trials and HIV care and treatment programs. The staff includes; 10 doctors, 3 pharmacists, 12 clinical officers, 25 nurses, 36 laboratory technologists and six 6 accountants among others. The CRS has a Community Advisory Board, strong community engagement programs, efficient participant recruitment, retention and follow-up processes. The CRS protocols are reviewed by the KEMRI and WRAIR IRBs. The CRS’s, secure physical infrastructure includes: 1) 13,400 square feet (sq. ft.) clinical research building for reception, waiting areas, clinical procedures, consultation, sample collection, pharmacy, quality assurance, IT servers, data entry, participants’ chart archives, and sample storage, 2) 26,115 sq. ft. Laboratory space, 3) two liquid nitrogen plants, 4) four back-up generators 5) 13,500 sq. ft. administration and 6) 6,000 sq. ft. store. Both the CRC pharmacy and laboratory are approved by the National Institute of Allergy and Infectious Diseases/Division of AIDS (NIAID/DAIDS) to participate in DAIDS sponsored vaccine (Site # 1502) and therapeutics (Site #12501) and International Maternal, Pediatric, and Adolescent AIDS Clinical Trials (IMPAACT) Group (Site # 5121) studies, the only research site with such approval in Kenya. The lab is also College of American Pathologists (CAP) accredited and consists of three main sections: HIV, Microbiology and Mycobacterium Tuberculosis (TB). The KEMRI/WRP CRC research activities are integrated with a large comprehensive public health HIV care, treatment and prevention program managed by KEMRI/WRP and supported by PEPFAR which covers a population of about 2.7 million people in the SRV which is also the CRS research catchment area. Elements supported by the program includes: antiretroviral therapy (ART), non-ART, TB/HIV co-infections, PMTCT, HIV Testing and Counseling (HTC), primary HIV infection prevention in both low and high-risk populations, Orphans and Vulnerable Children (OVC), and Voluntary Medical Male Circumcision (VMMC). Kenya had an estimated population in 2012 of 43 million people, 22% of whom are urban and with an annual population growth rate of 2.4%. The adult (15-64 years) HIV/AIDS prevalence rate is 5.6% (6.9% in women, and 4.4% in men). HIV prevalence among children aged 18 months to 14 years was 0.9%. In 2013, the country notified a total of 89,760 TB cases (all forms of tuberculosis) of whom 37% were also HIV infected and the South Rift Valley had a total of 4,302 TB cases in 2013.</p>\n
      • other_details_explanation<p>\n The trial will be conducted also in the host country of the sponsor</p>\n
      • other_details_regulatory_notapproved<p>\n WALTER REED ARMY INSTITUTE OF RESERACH(WRAIR IRB)- 26-07-2016</p>\n
      • other_details_regulatory_approved<p>\n CDC IRB- 15-10-2016</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorComparator is the standar
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/WRP, KERICHO
      • single_site_physical_addressP.O. BOX 1357, KERICHO
      • single_site_contact_personISAAC TSIKHUTSU
      • single_site_telephone0729 110 124
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states14
      • number_of_sites
      • multi_country_listKenya, Botswana, Malawi, South Africa, Uganda, USA, Spain, China, Vietnam, Peru, Zimbabwe, India, Thailand, Haiti
      • data_monitoring_committeeYes
      • total_enrolment_per_siteminimum 80, maximum 100
      • total_participants_worldwide2500
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • 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_consentYes
      • subjects_specifyWe will enroll children between 12 to 17 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBEATRICE
      • investigator1_middle_name
      • investigator1_family_nameKORIR
      • investigator1_qualificationKRN,BSN
      • investigator1_professional_addressP.O.BOX 1357 KERICHO
      • investigator1_telephone0702119191
      • investigator1_emailBeatrice.Korir@usamru-k.org
      • organisations_transferred_No
      • number_participants100
      • notification<p>\n N/A</p>\n
      • approval_date10-01-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-05-2020
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      • final_date(null)
      • modified2024-10-28 15:36:37
      • created2016-12-13 10:02:09
      • total_sites(null)
      • ecitizen_invoice(null)
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      • 0(array)
        • id373
        • application_id577
        • given_nameISAAC
        • middle_name
        • family_nameTSIKHUTSU
        • qualificationMBCHB,MMED,FPCCM
        • professional_addressP.O. BOX 1357 KERICHO
        • telephone0729 110 124
        • emailIsaac.Tsikhutsu@usamru-k.org
        • created2016-12-13 10:26:19
        • modified2020-05-18 11:12:00
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        • id470
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        • contact_person
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        • misc(null)
        • created2016-12-13 10:26:19
        • modified2020-05-18 11:12:00
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id299
        • application_id577
        • sponsorU.S. Centers for Disease Control and Prevention
        • sponsor_typeResearch Institution
        • contact_personKimberley Chapman
        • address1600 Clifton Road, Atlanta, Georgia USA 30329-4027
        • telephone_number(404) 639-7570/800-232-4636
        • fax_number
        • cell_number(404) 639-7570/800-232-4636
        • email_addresstbtcstudy31@cdc.gov
        • created2016-12-13 10:26:19
        • modified2020-05-18 11:12:00
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App Constants

CakePHP Constants

PHP Environment

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Include Paths

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Included Files

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    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php