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    • Application(array)
      • id270
      • user_id137
      • trial_status_id5
      • abstract_of_study<p>\n Parenteral immunization with killed whole cell bacteria is one of the oldest and most successful approaches to vaccine-induced protection against bacterial disease.  Whole cell vaccines have been applied to control epidemics and have considerably diminished the burden of vaccine preventable diseases over the last century.   A whole cell vaccine for protection of children from streptococcus pneumonia could solve the problems of complex manufacturing processes, high costs, adequate supply and broad serotype coverage which are all issues with the current pneumococcal conjugate vaccines. This study will be the first in a series of studies conducted in Kenya to assess whether PATH-wSP can induce immunity against pneumococcus. With a goal of developing a vaccine to be used in an infant EPI program.</p>\n<p>\n This study will utilize 600-µg and 1000-µg doses of PATH-wSP to provide a consistent dose across VAC 002 and VAC-010 (ie, 600 µg) and to explore a higher dose (1000 µg) to provide added immune and safety range data in adults. The current toxicology data support clinical trials up to 1000 µg for PATH‑wSP. Given the lack of response of most immune measurements below 600 µg as well as a safety profile that did not demonstrate dose or repeat vaccination concerns, the adult dose will be increased to 1000 µg in this study to observe for an optimal dose response. Following favorable safety results in adults, toddlers will be tested at doses of 300 and 600 mg. In addition, the upper boundary of 1000 mg in adults provides a safety margin for testing the 600-µg dose in toddlers.  </p>\n<p>\n The active control vaccines in toddlers (Synflorix and Pentavac) were chosen as they are the current vaccines given in the Kenyan infant vaccination program, and would be the vaccines given concomitantly when PATH-wSP is tested in the target infant population. The majority components of these 2 vaccines have been shown to induce boosting during the second year of life, and are recognized as providing additional benefit by either the WHO or included in country-specific labels for the individual components of the vaccines (WHO 2012, EMA 2011, CDC 2013). In addition, catch-up programs have shown these vaccines to be safe when given to toddlers. Currently the Kenya EPI program does not provide booster vaccinations for the second year of life. Toddlers in this trial will be receiving this health benefit of boosting antibody responses for those common childhood diseases.</p>\n<p>\n Further studies in infant populations will follow and will include (in addition to safety and immunogenicity) the effect on pneumococcal NPC. Ultimately, this data package will support a vaccine efficacy study in the pediatric population at high risk for pneumococcal disease in low-resource settings with the goal of achieving national/regional regulatory approval and WHO prequalification for access in such countries. </p>\n
      • study_title<p>\n A Phase 1/2 Randomized, Double-Blind, Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated<br />\n <em>Streptococcus pneumoniae</em> Whole Cell Vaccine Formulated with Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers (12-15 Months of Age)</p>\n<p align=\"center\">\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/02/03
      • version_no4.0
      • date_of_protocol19-12-2013
      • study_drugPATH-wSP
      • disease_conditionActive Immunization for the prevention of Pneumococcal disease
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
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      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskenya-vac010@fhi360.org
      • applicant_covering_letter1
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      • applicant_participating_countries0
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      • applicant_complete_form(null)
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      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
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      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGeorge Belai
      • declaration_date119-02-2014
      • declaration_principal_investigatorDr. Nekoye Otsyula, MBChB, MSc
      • declaration_date219-02-2014
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <strong>For Adults: </strong></p>\n<p style=\"margin-left:.25in;\">\n ·         Healthy young Kenyan adults between 18 to 45 (inclusive) years of age</p>\n<p style=\"margin-left:.25in;\">\n ·         Subjects who provide voluntary written informed consent to participate in the study and are capable of comprehending and complying with study requirements and procedures, able and willing to accept Field Staff visits and to return for all scheduled follow-up visits, and have expressed availability for the required study period, with access to a consistent means of telephone contact. If the subject is not literate, the subject will require a witness at signing or thumb-printing.</p>\n<p style=\"margin-left:.25in;\">\n ·         Adult female subjects who are not surgically sterile must have a negative serum pregnancy test on enrollment and a negative urine pregnancy test prior to each vaccination. Adult females will be advised through the informed consent process and during follow-up visits to avoid becoming pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. . Female subjects must have been utilizing an acceptable method of birth control for the previous 2 months prior to enrollment. If needed, the site can refer female subjects to a clinic so they can receive a birth control method.</p>\n<p style=\"margin-left:.25in;\">\n ·         Subjects willing to avoid consumption (ingestion) of chronic herbal medication that could have effects on liver function or bleeding indices during the course of the study.</p>\n<p>\n <strong>For Toddlers:</strong></p>\n<p>\n ·         Healthy Kenyan toddlers between 12 to 15 (inclusive) months of age who have completed their primary EPI vaccines, with the exception of the birth dose of oral polio vaccine not being required.</p>\n<p>\n ·         Subject's parent provides voluntary written informed consent for subject to participate in the study and is capable of comprehending and complying with study requirements and procedures, able and willing to accept Field Staff visits and to return for all scheduled follow-up visits, and has expressed availability for the required study period, with access to a consistent means of telephone contact. If the parent is not literate, the parent will require a witness at signing or thumb-printing.</p>\n<p>\n ·         Subjects who were not premature, had a birth weight of >2.5 kg, and who had a weight-to-height Z score of ≥ -2 at the time of enrollment.</p>\n<p>\n Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study (including herbal medication taken by a mother, which may transmit to a toddler through breast milk) that could have effects on liver function or bleeding indices during the course of the study.</p>\n
      • principal_exclusion_criteria<p>\n <strong>For All Subjects:</strong></p>\n<p style=\"margin-left:.25in;\">\n ·         Use of any investigational or nonregistered drug within 90 days prior to the administration of study vaccine or planned during the course of study participation.</p>\n<p style=\"margin-left:.25in;\">\n ·         History of administration of any vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation.</p>\n<p style=\"margin-left:.25in;\">\n ·         History of anaphylactic shock.</p>\n<p>\n ·         Positive test for malaria (blood film) at time of screening which remains positive post treatment when retested at Visit 1.</p>\n<p style=\"margin-left:.25in;\">\n ·         Immunosuppression or immunodeficiency (inclusive of human immunodeficiency virus [HIV], by medical history or by immunologic HIV testing at screening.</p>\n<p style=\"margin-left:.25in;\">\n ·         Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, as deemed by medical history or clinical assessment.</p>\n<p style=\"margin-left:.25in;\">\n ·         Evidence of active hepatitis infection (B or C) by immunologic testing at screening.</p>\n<p style=\"margin-left:.25in;\">\n ·         Any medical or social condition that in the opinion of the investigator will interfere with the study objectives or pose a risk to the study subject or may prevent the subject from completing the study follow-up.</p>\n<p style=\"margin-left:.25in;\">\n ·         An employee (or first degree relative of employee) of the Sponsor, the Clinical Research Organization (CRO), or any investigator or site personnel.</p>\n<p style=\"margin-left:.25in;\">\n ·         Any screening laboratory test result or vital sign measurement outside normal parameters and deemed by the clinician to be clinically significant, including a positive screen for malaria parasitemia.  Treatment and/or retesting of any laboratory test or vital sign measurement can occur one time during the screening period (2‑week window) and would still allow the subject to be randomized should the second test be normal; this includes treatment and rescreening for malaria parasitemia. The second test or vital sign measurement in these cases would be utilized as the baseline for all future assessments.</p>\n<p style=\"margin-left:.25in;\">\n ·         Acute illness (moderate or severe) and/or fever (tympanic temperature >38°C for adults and >37.5°C for toddlers), or any acute and limited illness requiring medical treatment, including the use of antibiotics and treatment for parasites. Note that subject may be treated/observed for resolution of the illness and/or fever and may be reevaluated for randomization as long as they remain within the 2-week screening window.</p>\n<p style=\"margin-left:.25in;\">\n ·         History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.</p>\n<p style=\"margin-left:.25in;\">\n ·         Disorders that require chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within the past 6 months prior to the administration of the study vaccine.  An immunosuppressant dose of glucocorticoid will be defined as a systemic dose >10 mg of prednisone per day for adults or equivalent in toddlers. The use of topical glucocorticoids will be permitted.</p>\n<p style=\"margin-left:.25in;\">\n ·         Administration of immunoglobulins and/or any blood products within the 6 months preceding enrollment in the study; or anticipation of such administration during the study period.</p>\n<p style=\"margin-left:.25in;\">\n ·         Known disturbance of coagulation or other blood disorder (eg, thalassemia, sickle cell disease, thrombocytopenia, disorders of the lymphocytes, severe anemia at birth, etc.) in adult subject or in self/first degree relative of toddler subject; or receipt of anticoagulants in the past 3 weeks (aspirin as needed and nonsteroidal anti-inflammatory drugs are acceptable).</p>\n<p style=\"margin-left:.25in;\">\n ·         History of meningitis or seizures or any neurological disorder (all participants) or major psychiatric disorder (adult).</p>\n<p>\n  </p>\n<p>\n <strong>Additional Exclusions for Adults:</strong></p>\n<p style=\"margin-left:.25in;\">\n ·         Female subjects who are pregnant or breast-feeding.</p>\n<p style=\"margin-left:.25in;\">\n ·         Suspicion or recent history (within the past year) of alcohol or substance abuse.</p>\n<p>\n <strong>Additional Exclusions for Toddlers:</strong></p>\n<p>\n ·         Subjects who has evidence of congenital abnormality or developmental delay.</p>\n<p>\n ·         Any evidence of fetal alcohol syndrome or history of alcohol abuse in mother during pregnancy.</p>\n<p>\n Subjects exposed to HIV or who are HIV positive by either antibody or polymerase chain reaction (PCR) testing. Subject will be excluded if the mother is HIV positive</p>\n
      • primary_end_points<p>\n Primary Endpoints:</p>\n<p>\n To assess the safety and tolerability following IM injection of PATH-wSP vaccine for the following:</p>\n<p>\n ·         Occurrence and severity of solicited local and systemic reactogenicity through 1 week post vaccination. </p>\n<p>\n ·         Occurrence, severity, and relatedness to vaccination of all AEs and serious adverse events (SAEs) through 4 weeks post vaccination</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifythis is a dose escalation and an age de-escalation study.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <strong>Staff list:</strong></div>\n<div>\n The research site is well equipped with various research specific expertises</div>\n<div>\n 9 Physician Principal Investigators; 7 Non-Physician Principal Investigators; 8 Clinical Research Coordinators; 1 project manager; 10 Clinical officers; 18 Research Nurses; 20 Laboratory technologists; 10 Laboratory technicians; 1 phlebotomist; 1 Pharmacist; 3 Pharmaceutical Technologists; 40 Fieldworkers</div>\n<div>\n <div>\n <strong>Operation Hours:</strong></div>\n <div>\n The clinic operates 24 hours 7 days a week including weekends and public holidays. All departments are sufficiently covered and operate fully from Monday to Friday 0800 to 1700 hours. After-hour including holidays and weekends only essential services are available with minimal staffing per department. Consultants/principal Investigators are always on call throughout and can be reached as necessary.</div>\n <div>\n <div>\n <strong>Clinic Services Package</strong></div>\n <div>\n The Walter Reed Project (WRP) is collaboration between the Kenya Medical Research Institute, (KEMRI) and the Walter Reed Army Institute of Research (WRAIR) ongoing for more than 40 years. The Kombewa Clinical Research Center (KCRC) is designed for large clinical trials and has a full clinical laboratory including microbiology capability. WRP-Kisumu also has a Demographic Surveillance System (DSS), which includes a population of over 150,000 people living in the former Kisumu-West District. It is located in Kombewa, 35 km from Kisumu across the road from Kombewa District Hospital. It comprises a clinical and microbiology lab, consultation rooms, a radiology unit with the capacity for digital radiography and a pharmacy capable of ensuring that blinding is maintained. The site has GCP trained staff experienced in phase I, II, and III vaccine trials with sample sizes ranging from 30 to 1631 and provision of clinical care to subjects enrolled in these trials.</div>\n <div>\n <div>\n <strong>Laboratory services:</strong></div>\n <div>\n We have clinical laboratory situated at the Kombewa Clinical Research Center and a basic Science laboratory situated at our premises within Kisumu town, next to the Jaramogi Oginga Odinga Teaching and Referral Hospital. Our Clinical laboratory is equipped to handle various tests including: Hematology, Biochemistry, Microbiology, and Microscopy. The Basic Science Laboratory has capability of Immunoglobuin isotyping analysis, Conventional and real time Quantitative Polymerase Chain Reaction (qRT-PCR, 8color (FACS Canto) flo-cytometry capabilities for phenotyping cellular surface molecules and intra-cellular staining, Cell culture including serum and serum free malaria culture system, DNA sequencing and fragment analysis using ABI Prism Gene Analyzer, HPLC analysis for hemoglobin genotype screening, Serological assay capabilities (ELISA), specimen storage-15 minus-80 degrees freezers with capability of 50.000 sample each.</div>\n <div>\n <div>\n <strong>Sample Collection, Handling and Results:</strong></div>\n <div>\n Samples collection is done at the phlebotomy room which is furnished with phlebotomy coaches/chairs and work tops. At the phlebotomy room clients are appropriately identified and logged in a log book capturing all the relevant details. After sample collection the sample is sent to the processing area where they are logged in, processed and analyzed as appropriate and the ones to be stored are transferred to storage area/freezer room where they are stored until when they are due for further analysis at the site or shipment to next destination as specified in the protocol/sample management manual. The results are usually provided in duplicates, reviewed and verified before they are dispatched to the clinician for patient management or to the data entry staff.</div>\n <div>\n <strong>Data Entry and Handling:</strong></div>\n <div>\n Date collection is done on source documents the transcribed into manual CRF or entered into eCRF. All data collected is identified using each client’s unique study number. All areas where paper and electronic data are stored have controlled access, the cabinets are lockable and the computers are password protected.</div>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The <em>Streptococcus pneumonia</em> vaccine (PATH-wSP) is a whole cell pneumococcal vaccine in development with specific intent for countries where the conjugate pneumococcal vaccines are cost prohibitive.  It is anticipated that this vaccine would be administered in conjunction with other vaccines currently endorsed by WHO for an infant Expanded Program on Immunization (EPI).  This would include combination vaccines that specifically have other whole cell components.  Therefore the development plan is designed to test PATH-wSP co-administered with a pentavalent combination vaccine which contains a whole cell pertussis component.  That is not the case in USA, where only acellular pertussis is being utilized.  In addition, the licensure pathway is to obtain a head to head trial against a pneumococcal conjugate vaccine for demonstrated efficacy to protect from pneumonia.  Such a trial would only be considered in a country where the rates of pneumonia remain high and where the potential to replace a costly conjugated vaccine with a whole cell vaccine would be endorsed by the Ministry of Health.  Kenya is viewed as a country where pneumonia remains an important cause of infant mortality and the desire to incorporate an effective and less costly vaccine against pneumococcus would be a major benefit for the Kenyan community.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration12 months in the field
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorSynflorix and Pentavac
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKenya Medical Research Institute (KEMRI)/Walter Reed Project, Kombewa Clinical Research Center
      • single_site_physical_addressKisumu - Kakamega Road Next to Regional Transfusion Center P.O. Box 54 - 40100 Kisumu, Kenya
      • single_site_contact_personDr. Nekoye Otsyula
      • single_site_telephone(+)254-722 239828
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site54 adults and 250 toddlers
      • total_participants_worldwide54 adults and 250 toddlers
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • 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_nameN/A. This is single centre study
      • investigator1_middle_name
      • investigator1_family_nameN/A. This is single centre study
      • investigator1_qualificationN/A. This is single centre study
      • investigator1_professional_addressN/A. This is single centre study
      • investigator1_telephoneN/A. This is single centre study
      • investigator1_emailNekoye.Otsyula@usamru-k.org
      • organisations_transferred_Yes
      • number_participants54 adults and 250 toddlers
      • notification
      • approval_date14-02-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-02-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-08-31 14:05:27
      • created2014-01-30 18:11:09
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id192
        • application_id270
        • given_nameNekoye
        • middle_nameNamungu
        • family_nameOtsyula
        • qualificationMBChB, MSc
        • professional_addressKenya Medical Research Institute (KEMRI)/Walter Reed Project Kisumu - Kakamega Road Next to Regional Transfusion Center P.O. Box 54 - 40100 Kisumu, Kenya
        • telephone(+)254-722 239828
        • emailNekoye.Otsyula@usamru-k.org
        • created2014-01-30 18:13:36
        • modified2014-02-19 16:06:55
      • 1(array)
        • id193
        • application_id270
        • given_nameWalter
        • middle_name
        • family_nameOtieno
        • qualificationMBChB, MMed, PhD
        • professional_addressKenya Medical Research Institute (KEMRI)/Walter Reed Project Kisumu - Kakamega Road Next to Regional Transfusion Center P.O. Box 54 - 40100 Kisumu, Kenya
        • telephone(+)254-714 481488
        • emailWalter.Otieno@usamru-k.org
        • created2014-01-30 18:16:31
        • modified2014-02-19 16:06:55
    • SiteDetail(array)
      • 0(array)
        • id239
        • application_id270
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-01-30 18:13:36
        • modified2014-02-19 16:06:55
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id151
        • application_id270
        • sponsorPATH Vaccine Solutions
        • sponsor_type(null)
        • contact_personDr. Cheryl Keech
        • address2201 Westlake Avenue, Suite 200 Seattle, WA 98121; USA
        • telephone_number(+1) 206-302-4669
        • fax_number
        • cell_number206-302-4669
        • email_addressckeech@path.org
        • created2014-01-30 18:13:36
        • modified2014-02-19 16:06:55
  • 1(array)
    • Application(array)
      • id278
      • user_id127
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background:</strong> According to KDHS 2008/9 the under 5-mortality rate has dropped from 115 per 1000 in 2003 KDHS, to 74 per 1000 in 2008, this represents an annual decline rate of 0.9%. Unless this rate is accelerated to at least 4.5%, Kenya is unlikely to meet MDG 4 by 2015. Integrated community case management (iCCM) coupled together with the administration of vitamin A supplements (VAS), is an important and viable option of reducing the mortality of children under the age of five <em>due to pneumonia, malaria and diarrhea</em>. Implementation of the iCCM in Kenya still remains inadequate. The main challenges to implementation include: inadequate training among the CHWs including little follow up post training in iCCM.</p>\n<p>\n <strong>The main objective</strong> is to determine whether trained, supervised and well supplied community health workers in hard to reach areas such as Homabay County can administer Vitamin A Supplements (VAS) and correctly perform iCCM and increase the proportion of children under five years receiving antibiotics for pneumonia, artementher-lumefantrine for malaria and zinc and oral rehydration therapy for diarrhoea by 20% compared to the baseline. On the other hand, despite efforts to improve vitamin A status among children through supplementation, advocacy for dietary diversification, bio fortification, industrial and home fortification of essential food commodities, VAD still remains a major public health problem in Kenya.  Studies have shown that about 42% of children under the age of five years in Sub Saharan Africa are at risk of VAD with Kenya at 76%. Achievement of Millennium Development Goal 4 of reducing under five mortality by two third by 2015, requires addressing or enhancing factors that contribute to child survival and development. Such factors include vitamin A supplementation and the integration of iCCM which will go a long way in reducing both maternal and child deaths.</p>\n<p>\n <strong>Methodology: </strong>The study will employ a pre and post design to compare iCCM and VAS health and process outcomes in Homabay County in Nyanza Province, Kenya during the intervention period, with those during a pre-intervention period. We will implement iCCM and VAS in a stepwise manner using a four-prong approach. The four prongs are 1) Sensitization of national, district, health center and community teams on iCCM and VAS 2) Training of the Community Health Extension Workers (CHEWS), CHWs and health care workers 3) Supervision and motivation of CHWs and 4) Commodity provision and accountability.</p>\n
      • study_title<p>\n Evaluating integrated community case management of pneumonia, malaria and diarrhoea among children under 5 years in Homabay County, Kenya.</p>\n
      • laymans_summary(null)
      • short_title Integrated community case management
      • protocol_noECCT/14/02/02
      • version_no1.4
      • date_of_protocol19-12-2013
      • study_drugAmoxicillin dispersible tablets [New formulation]
      • disease_conditionPneumonia
      • 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_nameAmoxicillin dispersible tablets
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmaricianah@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantPO BOX 614-40100 Kisumu, Tel No. +254 732 390 992 email: maricianah@yahoo.com
      • declaration_date123-02-2014
      • declaration_principal_investigatorDr. Onono Maricianah - Principal Investigator
      • declaration_date223-02-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n -Children aged 2months- 5 years<br />\n -Children suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • principal_exclusion_criteria<p>\n -Adults<br />\n -Children less than 2 months or over 5 years</p>\n<p>\n Children not suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • primary_end_points<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"732\">\n <tbody>\n <tr>\n <td style=\"width:160px;height:14px;\">\n <p>\n <strong>Primary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Proportion of children under 5 years with pneumonia who receive appropriate antibiotic treatment, compared to baseline</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:70px;\">\n <p>\n Proportion of CHWs who are able to rationally use antibiotics for treatment of pneumonia</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:83px;\">\n <p>\n Proportion of CHWs who appropriately account for supplied commodities</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use antimalarials</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use ORS and zinc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of mothers of children under 5 years who have symptoms of pneumonia or malaria who seek care from an appropriate provider</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children aged 6 to 59 months who received VAS on a semi-annual basis.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to correctly administer VAS, defined as giving vitamin A supplementation to children aged 6 to 59 months on a semi-annual basis in the County</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n <strong>Secondary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children treated for pneumonia who do not respond to treatment (experience treatment failure or relapse</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <br />\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Dr. Onono Maricianah:</strong> M.B.Ch.B, MSc Clinical Research  Global Health Fellowship- Principal Investigator<br />\n <strong>Dr. Bukusi Elizabeth:</strong> MBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics) - Co-Investigator<br />\n <strong>Akama Eliud:</strong> BSc, Diploma Community Health Nursing - Co-Investigator<br />\n <strong>Owuor Kevin</strong>: MSc Research Methods, BSc. Statistics - Co-Investigator/Statistician</p>\n<p>\n  </p>\n<p>\n <strong>Strength of the research team and f</strong><strong>easibility of project completion: </strong>The researchers in the study are part of the Kenya Medical Research Institute (KEMRI). Kenya Medical Research Institute (KEMRI) is a state corporation responsible for carrying out health research in Kenya. Since it's inception, KEMRI has developed a critical mass of scientists and technical personnel, to enable it mount a competitive research infrastructure to rank as a leading centre of excellence in health research both in Africa as well as globally. The researchers on this project have experience working in Nyanza province, specifically the Mbita district, in collaboration with the Ministries of Health in implementing a large scale HIV/AIDS program – the Family AIDS Care and Education Services (FACES). KEMRI will build on its experience and institutional knowledge gained from working in Homabay County. In Homabay County, KEMRI has over the years: 1) spearheaded community mobilization and built community linkages in alignment with the Government of Kenya (GoK) Community Strategy; 2) achieved rapid decentralization of services in underserved communities through family-based comprehensive HIV service provision; 3) improved the health system capacity in Mbita through training, mentorship, ongoing supervision, lab and pharmacy support, and logistics development; 4) successfully conducted clinical research including Microbicide research in partnership with the International Partnership for Microbicides (IPM); 5) established partnerships with GoK and other local institutions working in the area; and 6) attracted philanthropic support to help fund projects in the area e.g. the construction of the Comprehensive Care Clinic in Sindo District hospital (Steinberg building) and the Kar Geno Centre, Suba.7) Established the Fishermen hotline that allows the fishermen to dial in to be referred to the nearest health facilities providing antiretroviral therapy and the  <em>Uliza!</em> clinicians’ hotline hosted by Safaricom. The <em>Uliza!</em> hotline provides an opportunity for care providers in the periphery to call and receive mentorship from qualified medical doctors in the care of HIV patients. 8) KEMRI has already developed a robotic text messaging software built upon the RapidSMS platform. The software has been extensively tested and refined for the automated delivery of pre-defined text messages at specified times and in any preferred language. The proposed will use a similar platform and benefit from the expertise acquired.</p>\n<p>\n <strong>Organization</strong></p>\n<p>\n The study will have a study coordinator (clinical) and assistant coordinator (nutritionist), monitoring and evaluation specialist and a programmer. There will also be 6 sub-county coordinators in charge of the 6 sub counties in Homabay county. Further the study will employ 21 diploma nurses to do follow up for all pneumonia cases seen in the community</p>\n<p>\n The study will utilise existing community units in Homabay county. The community units must be actively reporting on a monthly basis as per records from the county health management team.</p>\n<p>\n The study will have a hotline number +254734919191 in which every time a community health worker sees a suspected pneumonia case, s/he will send a message which will trigger systems for the case to be verified by a trained nurse</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n<p>\n The trial will be conducted in Kenya which is the host country of the applicant. Both WHO and UNICEF which are the sponsors have country offices in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n -Kenya Medical Research Institute Ethical Research Committee (KEMRI- ERC) 21st May 2013 Homabay County</p>\n<p>\n <br />\n -World Health Organisation Research Ethics Review Committee (WHO ERC) 6th January 2014 Homabay County</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration24 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_stateYes
      • location_of_areaHomabay County
      • single_site_physical_addressLumumba Health Center, Agoi Street, PO BOX 614-40100 Kisumu-Kenya
      • single_site_contact_personDr. Maricianah Onono
      • single_site_telephone+254 732 390 992
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site888
      • total_participants_worldwideN/A
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • 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 under 5years.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB MMed OBGYN MPH PHD
      • investigator1_professional_addressP.O Box 19464- 00202 ,Nairobi
      • investigator1_telephone+254 720 617 503
      • investigator1_emailebukusi@kemri.org
      • organisations_transferred_Yes
      • number_participants888
      • notification<p>\n Dear Reviewers</p>\n<p>\n Rationale for Amoxicillin Dispersible Tablets (DTs) for Pneumonia in children</p>\n<p>\n The overall study is designed to determine whether CHWs can correctly diagnose pneumonia and treat them using Amoxicillin (suspension or dispersible tablets). As investigators we felt that given the evidence already existing for DTs that within the context of this implementation research project, we were best placed to use this amoxicillin DTs as they became available and measure outcomes at day 4 and 6 as per protocol. Currently the trained CHWs are already diagnosing and treating diarrhoea and malaria using Zinc DTs and Coartem DTs. They are also successfully diagnosing and treating pneumonia using Amoxicillin suspension in the community. A total of 192 children have been diagnosed and treated adn treatment confirmed by trained nurses. Given the success in use of DTs and in diagnosing and treating pneumonia, we believe now is the time to introduce the Amoxicllin DTs.</p>\n<p>\n Tablets and capsules can be difficult to swallow, and if perceived as bitter or unpleasant are often refused by childrenespecially when ill (WHO 2008). To overcome these problems, many paediatric medicines are given as liquid suspensions or syrups, with the taste masked by fruity or sweet flavourings. Effective drug administration in children requires formulations which allow for accurate weight or age- based dosing. With syrups and suspensions this is often done as full, half, or quarter spoonfuls, which has been shown to be inaccurate (Grießmann 2007). An alternative is to dispense measured syringes alongside medications. In a position statement on the preferred dosage forms for use in children, the World Health Organization now recommend that where available dispersible tablets should be chosen above suspensions due to advantages in dosing, storage, and transportation (WHO 2009). Dispersible amoxicillin has been identified as a priority medicine for the treatment of pneumonia; formulated as scored tablets of 250mg and 500mg, and packaged in blister packs of 10 (WHO/UNICEF 2010a ). Dispersible amoxicillin offers significant benefits over suspensions in terms of cost, product stability and ease of transport. Further, dispersable tablets have other advantages over the suspension such as 1) Dose accuracy: Dosing of liquids by spoon is unreliable. 2) Storage: Long shelf-life and no need for refridgeration 3) Transport: Less bulky and less susceptible to high temperatures. Paediatric dispersible tablets are already in use in Kenya for malaria, and well tolerated. Additionaly, based on WHO price lists, dispersible tablets could represent a cost saving compared to suspensions. (WHO/UNICEF 2010b).</p>\n<p>\n <strong>References</strong></p>\n<p>\n WHO 2008. The pathway to better medicines for children. 2008. Available at: http://www.who.int/childmedicines/Pathway.pdf</p>\n<p>\n Grießmann K, Breitkreutz J, Schubert-Zsilavecz et al. Dosing accuracy of measuring devices provided with antibiotic  oral suspensions. <em>Paediatric and Perinatal Drug Therapy</em><em>. </em>2007; <strong>8: </strong>61-70.</p>\n<p>\n <em>WHO technical report series; 958</em><em>. </em><em>The selection and use of essential medicines: report of the WHO Expert Committee, March 2009</em>. Geneva, World Health Organization, 2009.</p>\n<p>\n WHO/UNICEF 2010a. Priority essential medicines for child survival. 2010. Available at: http://www.who.int/childmedicines/progress/Unicef_prioriry_meds_child_survival.pdf</p>\n<p>\n WHO/UNICEF 2010b. Sources and prices of selected medicines for children including therapeutic food, dietary vitamin and mineral supplementation. 2010. Second edition. Available at: http://www.who.int/medicines/publications/essentialmedicines/Sources_Prices2010.pdf</p>\n
      • approval_date21-05-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-02-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n  </p>\n<h1>\n Operationalization of integrated community case management in Homabay County, Kenya</h1>\n<h1>\n Executive summary</h1>\n<p>\n In a Kenya Ministry of Health and WHO-supported exercise in 2011, Kenyan experts (academics, clinicians and policy-makers) generated and systematically scored research questions for maternal, newborn and child health interventions to reduce child mortality in Kenya using Child Health and Nutrition Research Initiative methodology. During this exerciseintegrated community case management (iCCM), which included pneumonia home case management was identified as a top priority for research in Kenya. To address this gap, in 2013, the Ministry of Health mandated the Kenya Medical Research Institute (KEMRI) with support from UNICEF and WHO to demonstrate the feasibility and effectiveness of training Community health workers (CHWs) and supplying them with Oral Rehydration Salts (ORS), zinc, rapid diagnostic tests (RDTs) for malaria, artemether-lumefantrin (AL) and amoxicillin to treat diarrhoea, malaria and pneumonia at the community level as envisaged in iCCM. This report describes the implementation strategies, processes and outcomes of an iCCM programme in Homabay County in western Kenya as part of large-scale countywide implementation. In addition, the report examines: i) concordance in identification and classification of lower chest indrawing between CHWs and nurses; ii) acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets versus oral suspension in treatment of children aged 2-59 months with pneumonia; iii)patient level costs of treating childhood pneumonia at home versus in the health facility; iv) quality of care provided by facility based health care workers vs. community health workers for pneumonia in sick children under 5 years; and v) the association between adherence and multiple drug prescription for pneumonia, malaria and diarrheal in children under five years of age by CHWs</p>\n<p>\n  </p>\n<p>\n <strong>Methods: </strong></p>\n<p>\n This was a prospective observational implementation research project. CHWs in Homabay County, Kenya were trained, equipped and supervised to implement iCCM for sick children aged 2-59 months. Implementation was conducted using a five-pronged approach which involved: i) sensitization of national, county, sub-county, health facility and community teams; ii) training of CHWs, community health extension workers and health care workers; iii) commodity provision and accountability; iv) supervision of CHWs; and v) monitoring and evaluation. Mobile phones were used to ascertain correct management of pneumonia by CHWs, monitoring and evaluation of service level statistics and commodity tracking.</p>\n<p>\n <strong>Key findings:</strong></p>\n<p>\n <strong>Service level statistics: </strong>A total of 2604 CHWs and 200 community health extension workers (CHEWs) from 242 community units received training in iCCM. Between October 2013 and March 2015, 170 079 children were assessed and classified by the CHWs. CHWs treated 11 693 pneumonia, 9869 malaria and 26 713 diarrhoea cases in the community, referred 8906 children to a health facility for immunization, and gave age-appropriate doses of vitamin A supplementation to 137 585 children. </p>\n<p>\n <strong>Concordance in identification and classification of lower chest indrawing pneumonia between CHWs and nurses:</strong>CHWs were able to identify, classify and treat lower chest in-drawing pneumonia in children aged 2-59 months with a five-day course of oral amoxicillin with low treatment failure rates in a real programme setting in Kenya. The concordance for classification of lower chest indrawing between CHWs and nurses was high (88.7% agreement) and the observed treatment failure rate was low (2.1%). The concordance for classification of fast breathing pneumonia between CHWs and nurses was high (97% agreement) with an inter-rater difference of only 2 breaths/count.  CHWs were more likely to misclassify lower chest indrawing in children with co-morbidities such as malaria and diarrhoea, those with moderate malnutrition or those whose caregivers delayed care seeking. This subset of children likely represents sicker children for whom extra care is needed in disease assessment and classification. </p>\n<p>\n <strong>Acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets:</strong>When compared to Amoxicillin oral suspension, Amoxicillin dispersible tablets had better treatment adherence among the sick children. Amoxicillin dispersible tables were also just as acceptable and as effective as the amoxicillin oral suspension in the treatment of pneumonia in children aged 2-59 months.</p>\n<p>\n <strong>Perceived quality of care provided by facility based health care workers vs. CHWs for pneumonia in sick children under 5 years: </strong>Caregivers rated the quality of CHW provided home-based management for childhood pneumonia to be higher than facility based health workers (FBHW) provided care.  We used the Primary Care Assessment Survey (PCAS), a patient-completed questionnaire that operationalizes formal definitions of primary care. The PCAS measures seven domains of care through 11 summary scales: accessibility (organizational, financial), continuity (longitudinal, visit-based), comprehensiveness (contextual knowledge of patient, preventive counseling), integration, clinical interaction (clinician-patient communication, thoroughness of physical examinations), interpersonal treatment, and trust.</p>\n<p>\n Caregivers rated CHWs higher in regards to ease of access (geographic and financial). This is likely because of both the spatial distribution of CHWs, as they live in the community and therefore are closer to clients, and the fact that CHWs don’t charge user fees for care or medications. CHWs were rated more highly than FBHWs in their ability to communicate with caregivers and instill trust. Patients answered positively when asked about the integrity, friendliness and support in decision-making by CHWs. Even in regards to clinical skills, the area in which FBHWs have a clear advantage, caregivers rated CHWs and FBHWs equally. One explanation could be that CHWs simply spend more time with the patients and are therefore able to perform a more thorough evaluation. In terms of overall satisfaction, CHWs were preferred to FBHWs when examining either a self-reported satisfaction score or a summary score that was calculated as the mean across all PCAS domains indicating acceptability</p>\n<p>\n <strong>Patient level costs of treating childhood pneumonia at home versus in the health facility. </strong>The estimated costs associated with treatment of a pneumonia episode in under-five children can be divided into direct and indirect out-of-pocket expenses incurred by the household for an episode of pneumonia.Direct medical costs are the actual amount paid by the households for consultation, investigations such as radiology, hospital admissions and medicines. Direct non-medical costs are incurred for transportation and meals for caregivers at the health facility. Indirect costs are the opportunity cost of caregiver time and fore gone wages during the time of seeking care for the child.The average total household cost of treatment of pneumonia was KSh. 194.36($2.04) and KSh 2201.64 ($23.18) for the caregivers that sort care from the CHW and health facility respectively. This is an 11-fold difference in cost of treatment. The cost of treatment of pneumonia has significant influence on subsequent health seeking behaviour as caregivers tend to subsequently seek care where it’s deemed cheaper for them. </p>\n<p>\n <strong>Effect of multiple drug prescription for pneumonia, malaria and diarrhoea on adherence in children under five years of age by CHWs: </strong>Among children classified as having pneumonia plus additional diarrhoea and or malaria, the treatment with combinations of anti-malarial, antibiotics and/ORS and zinc sulphate did not lower adherence compared to antibiotic alone. In addition, there was no difference in treatment failure in the two arms. </p>\n<p>\n  </p>\n<p>\n It is anticipated that with the evidence provided by this project, the Kenyan Ministry of health as well as the county health management teams will begin to adopt these practical solutions for iCCM regarding training, supplies and supervision.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Summary of recommendations:  </strong></p>\n<p>\n This large-scale implementation of iCCM in Homabay demonstrated practical approaches and models of providing services, linking community and health facility commodity management and strengthening the capacity of CHWs to manage common childhood illnesses in a community setting. The project established that when CHWs are trained, supervised and supported, they are able to have adequate knowledge, skills and competency to provide quality services including treatment of sick children. </p>\n<p>\n             The experience of this implementation project has important implications for expansion of iCCM in Kenya. We propose the following recommendations </p>\n<p style=\"margin-left:.25in;\">\n 1.    CHWs in this project demonstrated high competency rates and outranked facility based health care workers in terms of perceived quality of care and overall satisfaction. We therefore recommend that CHWs and iCCM be a key component of increasing access to treatment of childhood illnesses such as diarrhoea malaria and pneumonia to address child survival in Kenya </p>\n<p style=\"margin-left:.25in;\">\n 2.    Mechanisms of performance review and clinical accreditation of skills after basic training are needed in order to produce and maintain competency among CHWs; </p>\n<p style=\"margin-left:.25in;\">\n 3.    Availability of commodities to CHWs coupled with strong health facility-community linkages are crucial to success.</p>\n<p style=\"margin-left:.25in;\">\n 4.    Because CHWs experienced some challenge in classification of sicker children particularly those with moderate malnutrition, training curricula, needs to emphasize prompt identification and referral for all cases of moderate and severe malnutrition. CHWs should be able to identify and refer children with any danger sign and those with malnutrition. Additionally, caregivers need to be educated and motivated to seek appropriate care early</p>\n<p style=\"margin-left:.25in;\">\n 5.    Given the higher adherence rates and equivalence in effectiveness and acceptability, we recommend that Amoxicillin dispersible tablet be preferentially prescribed over the oral suspension for the treatment of pneumonia in children aged 2-59 months.</p>\n<p style=\"margin-left:.25in;\">\n 6.    Given that the household costs of iCCM of pneumonia were eleven times lower than facility based pneumonia treatment, we recommend the scale up of pneumonia treatment with oral amoxicillin at community level. Pneumonia home case management can significantly reduce household cost, improve access and better treatment outcomes to the underprivileged population, preventing many child deaths. It also has potential to decrease economic burden on the families besides decreasing pressure and cost on the already overburdened public health system.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-10-15 16:39:47
      • created2014-02-23 05:46:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id194
        • application_id278
        • given_nameMaricianah
        • middle_nameAtieno
        • family_nameOnono
        • qualificationMBChB MSC-Clinical Research Global health fellowship
        • professional_addressP.O Box 614 Postal Code 40100, Kisumu-Kenya
        • telephone+254 732 390 992
        • emailmaricianah@yahoo.com
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
    • SiteDetail(array)
      • 0(array)
        • id240
        • application_id278
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id152
        • application_id278
        • sponsorUNICEF
        • sponsor_type(null)
        • contact_personDr. Ketema Aschenaki Bizuneh
        • addressUNICEF, Kenya Country Office, P.O. Box 44145-00100,
        • telephone_number254 (20) 762 2209
        • fax_number254 (20) 762 27 46
        • cell_number+254 719 390 115
        • email_addresskbizuneh@unicef.org
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
      • 1(array)
        • id153
        • application_id278
        • sponsorWorld Health Organization
        • sponsor_type(null)
        • contact_personDr. Shamim Qazi
        • address20 Avenue Appia, Geneva 27, 1211 Switzerland
        • telephone_number(+41-22) 791-2547
        • fax_number(+41-22) 791-4853
        • cell_number(+41-22) 791-2547
        • email_addressqazis@who.int
        • created2014-02-23 06:06:38
        • modified2014-02-23 08:35:23
  • 2(array)
    • Application(array)
      • id264
      • user_id127
      • trial_status_id5
      • abstract_of_study<p>\n According to KDHS 2008/9 the under 5-mortality rate has dropped from 115 per 1000 in 2003 KDHS, to 74 per 1000 in 2008, this represents an annual decline rate of 0.9%. Unless this rate is accelerated to at least 4.5%, Kenya is unlikely to meet MDG 4 by 2015. Integrated community case management (iCCM) coupled together with the administration of vitamin A supplements (VAS), is an important and viable option of reducing the mortality of children under the age of five <em>due to pneumonia, malaria and diarrhea</em>. Implementation of the iCCM in Kenya still remains inadequate. The main challenges to implementation include: inadequate training among the CHWs including little follow up post training in iCCM.</p>\n
      • study_title<p>\n integrated community case management (iCCM) in Homabay County, Kenya</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/02/01
      • version_noversion 1
      • date_of_protocol28-01-2014
      • study_drugAmoxicillin Dispersable tablets
      • disease_conditionpneumonia, diarrhoea and malaria
      • 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_nameAmoxicillin dispersable tablets
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmaricianah@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicant+254 732 390 992
      • declaration_date128-01-2014
      • declaration_principal_investigatorDr. Onono Maricianah, Principal Investigator
      • declaration_date228-01-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n -Children under 5 years</p>\n<p>\n -Children suffering from Pneumonia, Diarrhoea and Malaria</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n -Adults</p>\n<p>\n -Children over 5 years</p>\n<p>\n -Emergency cases</p>\n<p>\n -Children not suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • primary_end_points<div>\n <p>\n - Proportion of under five years old children with pneumonia treated with antibiotics</p>\n <p>\n -Proportion of CHWs who are able to rationally use antibiotics for treatment of pneumonia</p>\n <p>\n -Proportion of CHWs who are able to account for essential iCCM drugs and commodities utilized every three months.</p>\n <p>\n -Proportion of mothers with sick infants who sought care from a CHW as the primary caregiver</p>\n <p>\n -Proportion of under five years old children who had a repeat visit from the CHW after initial treatment or referral</p>\n <p>\n -Proportion of CHWs who receive supervision for iCCM in the last 3 months</p>\n <p>\n -Proportion of under five children seen by the CHW and referred</p>\n <p>\n -Proportion of children aged 6 to 59 months who received VAS on a semi-annual basis.</p>\n <p>\n -Proportion of CHWs who are able to correctly administer VAS, defined as giving vitamin A supplementation to children aged 6 to 59 months on a semi-annual basis in the County</p>\n <p>\n -Proportion of children treated for pneumonia who do not respond to treatment (experience treatment failure or relapse)</p>\n</div>\n<p>\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Dr. Onono Maricianah, M.B.Ch.B, MSc Clinical Research - Principal Investigator</p>\n<p>\n Dr. Bukusi Elizabeth, MBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics) - Co-Investigator</p>\n<p>\n Akama Eliud, BSc, Diploma Community Health Nursing - Co-Investigator</p>\n<p>\n Owuor Kevin, MSc Research Methods, BSc. Statistics - Co-Investigator/Statistician</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n -Kenya Medical Research Institute</p>\n<p>\n -World Health Organisation</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration18 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_stateYes
      • location_of_areaHomabay County
      • single_site_physical_addressLumumba Health Center, Agoi Street, Kisumu-Kenya
      • single_site_contact_personDr. Onono Maricianah
      • single_site_telephone+254 732 390 990
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwideN/A
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • 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 under 5 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD .
      • investigator1_professional_addressP.O Box 19464- 00202 ,Nairobi
      • investigator1_telephone+254 720 617 503
      • investigator1_emailebukusi@kemri-ucsf.org
      • organisations_transferred_Yes
      • number_participants888
      • notification<p>\n N/A</p>\n
      • approval_date21-05-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted06-02-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-10-15 14:01:51
      • created2014-01-23 17:18:34
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id191
        • application_id264
        • given_nameMaricianah
        • middle_nameAtieno
        • family_nameOnono
        • qualificationMB.Ch.B MSc clinical research
        • professional_addressP.O Box 614 Postal Code 40100, Kisumu-Kenya
        • telephone+254 732 390 992
        • emailmaricianah@yahoo.com
        • created2014-01-28 16:02:03
        • modified2014-02-06 16:42:50
    • SiteDetail(array)
      • 0(array)
        • id238
        • application_id264
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-01-28 16:02:03
        • modified2014-02-06 16:42:50
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id150
        • application_id264
        • sponsorUNICEF & WHO
        • sponsor_type(null)
        • contact_personKetema Aschenaki Bizuneh
        • addressP.O. Box 44145-00100, UNICEF, Kenya Country Office
        • telephone_number254 (20) 762 2209
        • fax_number254 (20) 762 27 46
        • cell_number+254 719 390 115
        • email_addresskbizuneh@unicef.org
        • created2014-01-28 16:02:03
        • modified2014-02-06 16:42:50
  • 3(array)
    • Application(array)
      • id226
      • user_id97
      • trial_status_id6
      • abstract_of_study<p style=\"margin-left:4.5pt;\">\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">A randomized clinical controlled field trial in 360 randomly allocated primary school children aged 6 to 9 years with parental or guardian’s consent and attending selected schools in Kilifi District. The objective of the study is to determine the pre - and post - intervention impact of supplementation with iron and vitamin B12 singly and in combination on nutritional status, morbidity, haematological indices, serum ferritin, and serum vitamin B12 levels. Controls will be randomly allocated children receiving no intervention. Data collection will be by questionnaire on socio-demography, morbidity, 24 hour dietary recall, physical examination, anthropometric measurements, mid upper arm circumference, skin caliper thickness, class performance, total blood count; erythrocyte sedimentation rate, serum ferritin and vitamin B12 levels, This will be a repeat study design of above parameters at baseline, 3 months and six months. Collected information will be coded and cleaned. Exploratory Data Analysis will give descriptive statistics with frequencies, means, modes and median, quartile and inter-quartile ranges. Bivariate assessment will be done and categorical data subjected to Chi Square analysis and continuous data will be subjected to student t-test. Data with three or more variables will be subjected to ANOVA. Analysis will compare pre- and post- intervention variables between the study groups.</span></span></p>\n
      • study_title<p>\n <strong><span style=\"font-size: 16px;\">The Impact of Supplementation with Iron and Vitamin B12 Singly and In Combination on Nutritional Status and Morbidity Among Primary School Children.</span></strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/10/03
      • version_noFInal
      • date_of_protocol02-02-2012
      • study_drugOrofer and vitamin B12
      • disease_conditionMorbidity and Nutritional status
      • 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_nameIron III polymaltose complex and cyanocobalamin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspm_nyakundi@yahoo.co.uk
      • 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)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Priscilla M. Nyakundi
      • declaration_date116-10-2013
      • declaration_principal_investigatorDr. Priscilla M. Nyakundi
      • declaration_date216-10-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1<span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">. Primary school children<br />\n 2. Male and female<br />\n 3. Aged six (6) to nine (9) years. </span></span></p>\n<p>\n <span style=\"font-family: \'times new roman\', times, serif;\">4. Having an informed consent  signed by the parent or legal guardian</span></p>\n<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">5. Parent or legal guardian willing for child to stay on the study for the full study duration of six months.</span></span></p>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">1. A child outside the six to nine years age group.<br />\n 2. Unavailability of a signed informed consent by the parent or legal guardian<br />\n 3. A very sick child with a known chronic illness like HIV, kidney or hear disease.<br />\n 4. Unwillingness to stay the full duration of the study.<br />\n 5. A child in another study.<br />\n 6. A child on other micronutrient supplements.<br />\n 7. Severe case of malnutrition with complications</span></span><br />\n  </p>\n
      • primary_end_points<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">1. Morbidity incidence<br />\n 2. Change in nutritional status.<br />\n 3. Change in class performance</span></span></p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Staff</strong></p>\n<p>\n Dr. P. M. Nyakundi : MBCHB, M. MED., M. Sc., CTM. P.I.. - Coordinator</p>\n<p>\n Dr.Yeri Kombe : PhD. - JKUAT Supervisor.</p>\n<p>\n Prof. A. Makoha : PhD - JKUAT Supervisor.</p>\n<p>\n Rose Kiage : KCHN.</p>\n<p>\n Benson Oisebe : Pharmaceutical Technician.</p>\n<p>\n Stephen Onteri B. Sc.-  Biochemical analyst.</p>\n<p>\n Cleophas Paul Wayodi: Lboratory Technologist - Phlebotomist.</p>\n<p>\n Bernard Rotich Lboratory Technologist - Phlebotomist.</p>\n<p>\n Health teacher : 4 - monitor study cases in school for any adverse events.</p>\n<p>\n Community Health Workers : 18 - Monitor study cases at House Hold level for adverse events and 24 hour dietary recall.</p>\n<p>\n <strong>Site facilities</strong></p>\n<p>\n Available electricity supply in Ganze, Tsangalawen and Sokoke primary schools. Project staff will process the blood at Pwani Maternity Hospital in Kilifi.</p>\n<p>\n Four Cool boxes for transporting samples from site to laboratry.</p>\n<p>\n Two freezers</p>\n<p>\n Liquid nitrogen tanks will be used to freeze and store plasma.</p>\n<p>\n CPHR Nutrition laboratory will conduct the ferritn studies.</p>\n<p>\n University o Nairobi will assay the vitaminB12</p>\n<p>\n <strong>Emergency</strong></p>\n<p>\n Dr. P. M. Nyakundi</p>\n<p>\n Teresia Mamburi CCO : Ganze Health Centre.</p>\n<p>\n Leornard Baya : CHN, CHM : Sokoke Dispensary.</p>\n<p>\n Dr. Neema : Kilifi District Hospital.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not applicable.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n All approvals are from Kenyan authorities for the one trial site in Kilifi COunty.</p>\n<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">1. Centre For Public Health Research.  Approved: 23.3.2011<br />\n 2. KEMRI Scientific Steering Committee.Approved: 7th June 2011.<br />\n 3. KEMRI Ethics Review Committeee. Approved: February 2, 2012.<br />\n 4. Ministry of Public Health and Sanitation.Approved 27th February 2012.<br />\n 5. Ministry of Education.Approved 8th March 2012.<br />\n District Education Office, Director, Quality Assurance and Standards. Approved: 8th March 2012.<br />\n 6. Kilifi County, Ganze District. Approved: 9th October 2012.</span></span></p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationSix months.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorIron compared to vitamin
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKilifi County, Ganze District.
      • single_site_physical_addressDistrict Education Office, P. O. Box 6 GANZE.
      • single_site_contact_personMr. Jackson U. Daido
      • single_site_telephone04-17522556;
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteThe study has one site. Total cases 360.
      • total_participants_worldwide360
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyA six to nine year old child needs parental or guardian\'s informed consent in order to participate in the study.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namePriscilla
      • investigator1_middle_nameMonyangi
      • investigator1_family_nameDr. Nyakundi
      • investigator1_qualificationMBCHB,. M. MED. (paediatrics). M. Sc. (Immunology). C. T. M.
      • investigator1_professional_addressKenya Medical Research Institute, Centre for Clinical Research, P. O. Box 20778 - 00202, Nairobi
      • investigator1_telephone(254) 020 2722541; (254) 0722 523 609
      • investigator1_emailpm_nyakundi@yahoo.co.uk
      • organisations_transferred_No
      • number_participantsThree hundred and sixty (360) maximum
      • notification<p>\n No.</p>\n
      • approval_date02-02-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-10-2013
      • 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)
      • modified2014-04-02 21:54:47
      • created2013-10-11 22:02:24
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id157
        • application_id226
        • given_namePriscilla
        • middle_nameMonyangi
        • family_nameDr. Nyakundi
        • qualificationMBCHB, M. MED. (Paediatrics) M. SC (Immunology), C. T. M., PhD in progress
        • professional_addressKenya Medical Research Institute, Centre for CLinical Research
        • telephone(254) 020 2722541; (254) 0722 523 609
        • emailpm_nyakundi@yahoo.co.uk
        • created2013-10-11 22:10:35
        • modified2013-10-27 03:11:01
    • SiteDetail(array)
      • 0(array)
        • id197
        • application_id226
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-10-11 22:10:35
        • modified2013-10-27 03:11:01
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id123
        • application_id226
        • sponsorP. I., Dr. Priscilla Monyangi Nyakundi
        • sponsor_type(null)
        • contact_personDr. Priscilla Monyangi Nyakundi
        • addressKenya Medical Research Institute, Centre for Clinical Research, P. O. Box 20778 - 00202, Nairobi
        • telephone_number(254) 020 2722541
        • fax_number020 2720030
        • cell_number(+254) 0722 523 609
        • email_addresspm_nyakundi@yahoo.co.uk
        • created2013-10-11 22:10:35
        • modified2013-10-27 03:11:01
  • 4(array)
    • Application(array)
      • id255
      • user_id113
      • trial_status_id6
      • abstract_of_study<p>\n According to KAIS 2012, approximately 1.2 Million Kenyans are living with HIV and AIDs, HIV prevalence stands at 5.6 %. ART is a lifelong therapy for HIV infected individuals. The ARV medicines are associated with safety concerns ranging from minor to more serious Adverse Drug Reactions (ADRs). These ADRs can have both short and long-term effects for clients on ARVs.</p>\n<p>\n There has been limited toxicity monitoring or systematic documentation and reporting of ADRs in the ART sites.  There is limited information on ADRs prevalence and risk factors associated with the use of ARVS amongst ART clients in Kenyans. It is therefore important to put in place a system to strengthen the identification, documentation, reporting and monitoring of ADRs amongst ART patients in Kenya. The overall goal of the study is to contribute towards drug safety for clients hence improve quality of care.  The main objective is to determine the safety of ARVs among cohorts of clients initiating ART in selected health facilities</p>\n<p>\n This CEM will be a multicenter prospective observational study, free of selection bias, inceptional (each patient will be monitored from the beginning of treatment), dynamic (new patients will be added as the program proceeds), longitudinal (effects will be studied over a defined time period) and descriptive. The study population is adult and pediatric clients newly initiating on ART.  A sample size of 10,000 clients initiating clients in 8 sampled sites across the country shall be recruited and followed up for 24 months.  Ethical approval to implement the protocol shall be obtained from PPB.</p>\n<p>\n The findings of CEM will help MOH/NASCOP as well as other stakeholders gain additional knowledge on adverse drug effects related to ARV regimens in Kenya. It will help in rolling out interventions that shall improve tolerability and effectiveness of ART, promoting the early recognition and reversal of potentially serious adverse effects and reducing the potential for adverse drug interactions. It will also improve adherence to ART.</p>\n
      • study_title<p>\n <strong>Cohort Event Monitoring of Antiretroviral Medicines Use in Kenya</strong></p>\n
      • laymans_summary(null)
      • short_titleCEM ART
      • protocol_noECCT/13/10/02
      • version_no1
      • date_of_protocol30-09-2013
      • study_drugAntiretrovirals
      • disease_conditionHIV
      • 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_nameTenofovir, Lamivudine, Zidovudine, Abacavir, Nevirapine, Efavirenz, Lopinavir/ritonavir
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresscolwande@nascop.or.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicant+254724416764
      • declaration_date108-01-2014
      • declaration_principal_investigatorDr Caroline Olwande
      • declaration_date208-01-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p style=\"margin-left:.75in;\">\n i.                    ARV naive adult and pediatric patients , commencing HAART at the site during the study period</p>\n<p style=\"margin-left:.75in;\">\n ii.                  All adults> 18 years of age and able and willing to provide informed consent</p>\n<p style=\"margin-left:.75in;\">\n iii.                Parents or caregivers of recruited pediatrics participants of age <18 years willing to provide written consent or oral consent for participate in the surveillance</p>\n<p style=\"margin-left:.75in;\">\n iv.                 Able and willing to provide adequate information for locator purposes.</p>\n<p style=\"margin-left:.75in;\">\n v.                   Not intending to relocate out of the area for the duration of study participation and  not having  an occupation  or other obligations that may require long absences from the area </p>\n
      • principal_exclusion_criteria<p>\n i.                    Patients or parents/legal guardians not willing to provide signed informed consent.</p>\n<p>\n ii.                  Previous or current participation in a HIV vaccine study.</p>\n<p>\n iii.                Active alcohol or substance abuse.</p>\n<p>\n iv.                 A history of mental illness.</p>\n<p>\n v.                   Prisoner status</p>\n
      • primary_end_points<p>\n <span style=\"font-size: 12pt; font-family: Calibri, sans-serif;\">Patients shall be recruited into the cohort from 8 sites within a period of 24 months starting from January 2014 up to when a cohort of 10,000 has been achieved. Each patient will be followed up for a maximum of 24 months after which the client exits the study; therefore the maximum period in a given site will be 48-months. </span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • 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_other1
      • trial_other_specifyThis is a multicenter prospective, observational longitudinal study of clients initiating antiretroviral therapy to characterize the safety of use of the medicines
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The 8 sites selected for CEM had the highest scores of 17 facilities assessed based on the following creiteria: </p>\n<p style=\"margin-left:.5in;\">\n         i.            Patient volumes (facility recruitment rate)</p>\n<p style=\"margin-left:.5in;\">\n       ii.            Sites actively initiating both adult and  pediatric clients on HAART</p>\n<p style=\"margin-left:.5in;\">\n     iii.            Sites actively reporting ADRs to the national pharmacovigilance center</p>\n<p style=\"margin-left:.5in;\">\n      iv.            Sites with adequate, willing and committed personnel</p>\n<p style=\"margin-left:.5in;\">\n        v.            Sites with adequate infrastructure to enable efficient and effective follow up of clients and documentation.</p>\n<p style=\"margin-left:.5in;\">\n      vi.            Sites with functional CCC multidisciplinary team and/or medicines and therapeutics committees</p>\n<p style=\"margin-left:.5in;\">\n    vii.            A commitment from the site to continue follow-up of patients for up to 4 years after enrolment</p>\n<p style=\"margin-left:.5in;\">\n  viii.            A reasonable size of currently followed up patients on which adequate data are already being collected.</p>\n<p style=\"margin-left:.5in;\">\n      ix.            Facilities demonstrating best practices with compliance to National ART guidelines</p>\n<p>\n        x.            Sites with functional laboratory facilities and ability to implement quality assurance measures</p>\n<p>\n      xi.            Sites with previous experience of CEM</p>\n<p>\n    xii.            Acceptance of organization and publication rules of the project.</p>\n
      • other_details_explanation<p>\n The study is to be conducted in Kenya, coordinated by NASCOP and PPB with funding support from the Global Fund Single Stream Funding project. </p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration4 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_sitesEight
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site1250 in each of the 8 sites
      • total_participants_worldwide10,000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerYes
      • 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_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameCaroline
      • investigator1_middle_name
      • investigator1_family_nameOlwande
      • investigator1_qualificationBachelor of Pharmacy; MSc Pharmaceutical services and medicines control
      • investigator1_professional_addressNational AIDS and STI Control Program, KNH grounds, Nairobi
      • investigator1_telephone+254724416764
      • investigator1_emailcolwande@nascop.or.ke
      • organisations_transferred_Yes
      • number_participants10,000
      • notification
      • approval_date30-09-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-02-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2019-03-25 14:22:50
      • created2014-01-08 10:03:07
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id181
        • application_id255
        • given_nameCaroline
        • middle_name
        • family_nameOlwande
        • qualificationBachelor of Pharmacy; MSc Pharmaceutical services and medicines control
        • professional_addressNational AIDS and STI Control Program, KNH grounds, Nairobi
        • telephone+254724416764
        • emailcolwande@nascop.or.ke
        • created2014-01-08 11:30:56
        • modified2014-02-11 13:08:46
      • 1(array)
        • id182
        • application_id255
        • given_nameIrene
        • middle_name
        • family_nameMukui
        • qualificationMBCHB; National Antiretroviral Therapy program manager
        • professional_addressNational AIDS and STI Control Program, KNH grounds, Nairobi
        • telephone+254722387986
        • emailimukui@nascop.or.ke
        • created2014-01-08 11:30:59
        • modified2014-02-11 13:08:46
      • 2(array)
        • id183
        • application_id255
        • given_nameMaureen
        • middle_name
        • family_nameKimani
        • qualificationMBCHB
        • professional_addressNational AIDS and STI Control Program, KNH grounds, Nairobi
        • telephone+254721587511
        • emailmaureen.nyambura@nascop.or.ke
        • created2014-01-08 11:47:47
        • modified2014-02-11 13:08:46
      • 3(array)
        • id184
        • application_id255
        • given_nameEdward
        • middle_name
        • family_nameAbwao
        • qualificationBachelor of Pharmacy; MSc Medical statistics
        • professional_addressPharmacy and Poisons Board, Lenana road, Nairobi
        • telephone+254722644824
        • emailedwardabwao@gmail.com
        • created2014-01-08 11:47:47
        • modified2014-02-11 13:08:46
      • 4(array)
        • id185
        • application_id255
        • given_nameNdinda
        • middle_name
        • family_nameKusu
        • qualificationBachelor of Pharmacy; Masters in clinical pharmacy
        • professional_addressManagement Sciences for Health/HCMP project
        • telephone+254720735456
        • emailnkusu@msh.org
        • created2014-01-08 11:47:47
        • modified2014-02-11 13:08:46
      • 5(array)
        • id186
        • application_id255
        • given_nameMaureen
        • middle_name
        • family_nameKimani
        • qualificationMBCHB
        • professional_addressNational AIDS and STI Control Program, KNH grounds, Nairobi
        • telephone+254721587511
        • emailmaureen.nyambura@nascop.or.ke
        • created2014-01-08 11:47:48
        • modified2014-02-11 13:08:46
      • 6(array)
        • id187
        • application_id255
        • given_nameEdward
        • middle_name
        • family_nameAbwao
        • qualificationBachelor of Pharmacy; MSc Medical statistics
        • professional_addressPharmacy and Poisons Board, Lenana road, Nairobi
        • telephone+254722644824
        • emailedwardabwao@gmail.com
        • created2014-01-08 11:47:48
        • modified2014-02-11 13:08:46
      • 7(array)
        • id188
        • application_id255
        • given_nameNdinda
        • middle_name
        • family_nameKusu
        • qualificationBachelor of Pharmacy; Masters in clinical pharmacy
        • professional_addressManagement Sciences for Health/HCMP project
        • telephone+254720735456
        • emailnkusu@msh.org
        • created2014-01-08 11:47:48
        • modified2014-02-11 13:08:46
    • SiteDetail(array)
      • 0(array)
        • id229
        • application_id255
        • county_id19
        • site_nameNyeri Provincial General Hospital
        • physical_addressNyeri town
        • contact_details0715727281
        • contact_personDr Robert Kamau
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 11:30:56
        • modified2014-02-11 13:08:46
        • County(array)
          • id19
          • county_nameNyeri
          • created2012-06-15 10:24:16
          • modified2012-06-15 10:24:16
      • 1(array)
        • id230
        • application_id255
        • county_id22
        • site_nameThika Level 5 Hospital
        • physical_addressThika town
        • contact_details0723804822
        • contact_personJudy Kariuki
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 11:30:59
        • modified2014-02-11 13:08:46
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 2(array)
        • id231
        • application_id255
        • county_id16
        • site_nameMachakos Level 5 Hospital
        • physical_addressMachakos town
        • contact_details0721250668
        • contact_personDr Robert Koech
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 12:16:12
        • modified2014-02-11 13:08:46
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 3(array)
        • id232
        • application_id255
        • county_id38
        • site_nameVihiga District Hospital
        • physical_addressVihiga town
        • contact_details0722571509
        • contact_personDr John Kaguthi
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 12:16:12
        • modified2014-02-11 13:08:46
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
      • 4(array)
        • id233
        • application_id255
        • county_id45
        • site_nameKisii Level 5 Hospital
        • physical_addressKisii town
        • contact_details0723569000
        • contact_personDr Kimutai Cheruiyot
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 12:16:12
        • modified2014-02-11 13:08:46
        • County(array)
          • id45
          • county_nameKisii
          • created2012-06-15 10:27:25
          • modified2012-06-15 10:27:25
      • 5(array)
        • id234
        • application_id255
        • county_id44
        • site_nameSt Camillus Mission Hospital
        • physical_addressKarungu
        • contact_details0735378483
        • contact_personDr Bertha Ruhogo
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 12:16:12
        • modified2014-02-11 13:08:46
        • County(array)
          • id44
          • county_nameMigori
          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
      • 6(array)
        • id235
        • application_id255
        • county_id32
        • site_nameNakuru Provincial General Hospital
        • physical_addressNakuru town
        • contact_details0723529133
        • contact_personDr Obadiah Naikuni
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 12:16:12
        • modified2014-02-11 13:08:46
        • County(array)
          • id32
          • county_nameNakuru
          • created2012-06-15 10:25:52
          • modified2012-06-15 10:25:52
      • 7(array)
        • id236
        • application_id255
        • county_id1
        • site_nameCoast Provincial General Hospital
        • physical_addressKisauni road, Mombasa
        • contact_details0728625918
        • contact_personDr Emily Siminyu
        • site_capacity(null)
        • misc(null)
        • created2014-01-08 12:16:12
        • modified2014-02-11 13:08:46
        • County(array)
          • id1
          • county_nameMombasa
          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
    • Sponsor(array)
      • 0(array)
        • id147
        • application_id255
        • sponsorThe Global Fund
        • sponsor_type(null)
        • contact_personDr Sarah Masyuko
        • addressP.O.BOX 19361-00202, Nairobi
        • telephone_number+2542729502
        • fax_number
        • cell_number+254725718318
        • email_addresssmasyuko@nascop.or.ke
        • created2014-01-08 11:30:56
        • modified2014-02-11 13:08:46
• page_options(array)
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• redir
• $request->data(array)
  • Application(array)
    • approved1
• $this->validationErrors(array)
  • Permission(empty)
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  • Application(empty)
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  • County(empty)
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  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
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  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

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