Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
561. |
ECCT/11/08/04 | SSG/PM Pharmacovigilance Plan Pharmacovigilance Plan to Monitor the Safety and Effectiveness of Combination of Sodium Stibogluconate and Paramomycin in the Treatment of Visceral Leishmaniasis The SSG/PM (Sodium Stibogluconate/Paromycin) Pharmacovigilance Plan aims to collect pharmacovigilance information during the early post-approval period of SSG/PM as soon as SSG/PM is in use by the Ministries of Health for treatment of Visceral Leishmaniasis. During the early post-approval period, SSG/PM might be used in settings different from clinical trials and a much larger and diverse population might be exposed in a relatively short timeframe. The pharmacovigilance (PV) programme is crucial in order to continuously evaluate the risk-benefit ratio in different groups of patients and in different contexts The Pharmacovigilance study in Kenya involves the key sentinel site of Kacheliba kala-azar treatment centre, (where MSF-OCG is based). A similar protocol is ongoing in Sudan and planned for Uganda. The Pharmacovigilance plan primary objectives are: a) to continuously monitor the safety profile of SSG/PM during the first 2 years that follow its authorization for use in East Africa; b) to identify additional risks that have not been reported in pre-approval clinical studies; c) to determine whether SSG/PM adverse reactions are of higher concern in specific groups of patients; d) to monitor the treatment failure rate of SSG/PM and e) to monitor any evidence in site variation in terms of SSG/PM effectiveness and safety. The target population are all VL patients treated with SSG/PM in Kenya and other participating countries. A registry is used independently from clinical presentation and demographic characteristics. Diagnostic, treatment and discharge procedures are consistent with the routine clinical practice in use in the health facility. A standard form is used to collect information. No blood/tissue samples or extra medical procedures are required for the PV plan. Every 3 months, descriptive statistics are produced. In particular, the total number of SAE, the number of treatment-related SAE and the number of treatment failures are calculated. The Steering Committee is responsible for data review. In Kenya Ethical and Regulatory approval is sought through KEMRI ERC and Pharmacy and Poisons Board. Informed consent document is distributed to each patient treated with SSG/PM. The aim of the PV plan is discussed, as well as the measures taken to ensure confidentiality of the data collected. |
Principal Investigator(s) 1. Monique Wasunna Site(s) in Kenya 1. Kacheliba Kala-azar treatment centre (West Pokot county) 2. Kimalel Health Centre (Baringo county) |
13-05-2012 |
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562. |
ECCT/11/08/03 | Compare the Efficacy and Safety of Gentian Violet to that of Nystatin A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Topical Gentian Violet to that of Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings |
Principal Investigator(s) 1. Deborah C Langat Site(s) in Kenya 1. Kenya Medical Research Institute Walter Reed Project Clinical Research Centre (Kericho county) 2. Moi University Clinical Research Centre (Uasin Gishu county) |
22-11-2012 |
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563. |
ECCT/11/07/02 | REMEMBER A5274/REMEMBER "Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens" |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Moi University Clinical Research Centre (Uasin Gishu county) 2. Walter Reed Project (Kericho county) |
29-10-2010 |
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564. |
ECCT/11/04/01 | A Double-blind, Randomized Trial of Monthly Treatment with Metronidazole and Miconazole Co-formulated Suppositories versus Placebo for Preventing Vaginal Infections in HIVSeronegative Women (DMID Protocol Number: 09-0070) |
Principal Investigator(s) 1. Raymond Scott McClelland Site(s) in Kenya 1. Kenya AIDS Vaccine Initiative (Nairobi City county) 2. Kenya AIDS Control Program (Nairobi City county) 3. Mombasa HIV/STD Research Clinic (Mombasa county) |
23-06-2011 |
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565. |
ECCT/11/02/01 | Compare the Efficacy and Safety of Gentian Violet to that of Nystatin A5265 - A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Topical Gentian Violet to that of Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Moi University Clinical Research Centre (Uasin Gishu county) 2. KEMRI Walter Reed Project (Kericho county) |
19-03-2010 |
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566. |
ECCT/11/01/02 | EARNEST EARNEST : Europe -Africa Research Network for Evaluation of Second-line Therapy |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya Moi University Clinical Research Centre |
06-09-2010 |
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567. |
ECCT/10/11/06 | Randomized Comparison of ART Alone versus ART with Immediate Chemotherapy A5264/AMC 067 "A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Li1mited Stage AIDS-KS in Resource-Limited Settings (REACT-KS)" |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Walter Reed Project Kericho (Kericho county) 2. Moi University Clinical Research Centre (Uasin Gishu county) |
04-08-2010 |
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568. |
ECCT/10/11/03 | ASMQ Study Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine Combination for the Treatment of Uncomplicated Falciparum Malaria in African Children versus Artemether-Lumefantrine |
Principal Investigator(s) 1. Bearnhards Ogutu Ragama Site(s) in Kenya The Kenya Medical Research Institute (KEMRI), Kisumu, Kenya |
07-02-2011 |
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569. |
ECCT/10/09/05 | A5225/ HiFLAC A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis A Multicenter Trial of the AIDS Clinical Trials Group (ACTG) |
Principal Investigator(s) 1. Deborah Chepngeno langat Site(s) in Kenya 1. |
08-02-2013 |
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570. |
ECCT/10/09/03 | A0661201 A0661201 AN OPEN LABEL, NON-COMPARATIVE STUDY TO EVALUATE PARASITOLOGICAL CLEARANCE RATES AND PHARMACOKINETICS OF AZITHROMYCIN AND CHLOROQUINE FOLLOWING ADMINISTRATION OF A FIXED DOSE COMBINATION OF AZITHROMYCIN AND CHLOROQUINE (AZCQ) IN ASYMPTOMATIC PREGNANT WOMEN WITH PLASMODIUMFALCIPARUM PARASITEMIA IN SUB-SAHARAN AFRICA |
Principal Investigator(s) 1. Joshua Kimani Site(s) in Kenya University of Nairobi Institute of Tropical and Infectious Diseases Siaya District Hospital |
25-09-2013 |
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