Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
301. |
ECCT/14/06/01 | ACTG -5279 Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals with Latent Tuberculosis Infection |
Principal Investigator(s) 1. Dr. Kevin N/A Cain Site(s) in Kenya 1. KEMRI/WRP CRS (Kericho county) 2. Moi University Clinical Research Center CRS ()12601 (Uasin Gishu county) |
30-06-2014 |
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302. |
ECCT/20/12/01 | KU ‘TIBA VENT\' Phase I/II, Open Label Randomized Controlled Trial Evaluating Safety of 'KU TIBA VENT" For Mechanical Ventilation in Patients With Respiratory Failure During Weaning Phase Abstract KU TIBA VENT There is ongoing pandemic caused by SARS-Cov-2, commonly referred to us COVID-19 that started in China in December 2019. The patients develop acute respiratory failure requiring machine assisted breathing. However, due to the huge numbers affected patients, the demand for mechanical ventilators outstrip supply worldwide. This is especially so in Kenya with poor health systems. In response to the increased demand for mechanical ventilators, a group of students plus their lecturer mentors at Kenyatta University responded by designing and producing a ‘TIBA VENT” from locally available materials. The design and production processes have been evaluated by the Kenya Bureau of Standards and found to be in conformity with the countries standards. We have designed a protocol to guide clinical validation before registration by Pharmacy and Poisons Board as part of requirement for commercialization. The main objective of this clinical validation is to assess the dependability and reliability of the device when connected to patients in the intensive care Unit. The secondary end points are to assess the functionality of the control variables, the trigger settings as well as user concerns to facilitate design modifications before roll out. The clinical validation will be done at Kenyatta University Teaching, Research and Referral Hospital (KUTRRH). This is a phase II of study with expected duration of 14 days and enrolling at least 4 patients. The sponsor for the study is the Kenyatta University. The information obtained will assist in design modifications before commercialization. This is an example of homegrown innovation. |
Principal Investigator(s) 1. Gordon Oluoch Ogweno Site(s) in Kenya Kenyatta University Teaching Research and Referral Hospital (KUTRRH) |
09-06-2021 |
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303. |
ECCT/20/09/01 | PrEP in Pharmacy - PILOT STUDY Pharmacy delivery to expand the reach of PrEP in Kenya: Pilot study |
Principal Investigator(s) 1. Kenneth Kairu Ngure Site(s) in Kenya KEMRI-CCR PHRD (THIKA) PROJECT |
28-10-2020 |
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304. |
ECCT/23/02/05 | Pharmacy PrEP cRCT Pharmacy delivery to expand the reach of PrEP in Kenya: cluster-randomized control trial |
Principal Investigator(s) 1. Elizabeth Anne Bukusi 2. Kenneth Ngure Site(s) in Kenya 1. Kenya Medical Research Institute, Center for Microbiology Research, Research Care and Training Programme (KEMRI-CMR-RCTP) research center (Kisumu county) 2. Kenya Medical Research Institute, Center for Clinical Research, Partners in Health and Research Development (KEMRI-CCR-PHRD) research center (Kiambu county) |
07-06-2023 |
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305. |
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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306. |
ECCT/24/02/05 | Doxo-study Pharmacokinetic profiles for Doxorubicin among children with childhood cancer in Kenya. |
Principal Investigator(s) 1. Festus MUIGAI Njunguna Site(s) in Kenya MOI UNIVERSITY SCHOOL OF MEDICINE |
20-09-2024 |
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307. |
ECCT/13/07/03 | Pharmacokinetic and pharmacodynamic studies of efficacy, tolerability and safety of higher dosage rifapentine for treatment of tuberculosis |
Principal Investigator(s) 1. Dr Lena Matata Site(s) in Kenya KEMRI-CDC |
07-12-2011 |
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308. |
ECCT/24/04/07 | FORMATIVE-PEARLS TRIAL PEARLS FORMATIVE (Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening) |
Principal Investigator(s) 1. Zahida Qureshi 2. Alfred Osoti 3. George Gwako 4. Rosa Chemwey Site(s) in Kenya 1. Kakamega General County Teaching and Referral Hospital (Kakamega county) 2. Jaramogi Oginga Odinga Teaching and Referral Hospital (Kisumu county) 3. Kiambu Level 5 Hospital (Kiambu county) 4. Kisii Teaching and Referral Hospital (Kisii county) 5. Meru Teaching and Referral Hospital (Meru county) |
05-07-2024 |
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309. |
ECCT/17/08/02 | IMPROVE (Improving PRegnancy Outcomes with intermittent PReVEntive treatment in Africa) IPTp with dihydroartemisinin-piperaquine and azithromycin for malaria, sexually transmitted and reproductive tract infections in pregnancy in high sulphadoxine-pyrimethamine resistance areas in Kenya, Malawi and Tanzania: an international multi-centre 3-arm placebo-controlled trial |
Principal Investigator(s) 1. Simon Kariuki Site(s) in Kenya 1. Migori County Referral Hospital (Migori county) 2. Homa Bay County Referral Hospital (Homa Bay county) 3. Rongo Sub-County Hospital (Migori county) 4. Ahero Sub-County Hospital (Kisumu county) 5. Rabuor Sub-County Hospital (Kisumu county) |
07-09-2017 |
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310. |
ECCT/21/08/02 | IPrEP Men\'s Study IPrEP Men’s Study: Expanding the reach of prevention for men in Kisumu, Kenya |
Principal Investigator(s) 1. Kawango Agot 2. Wafaa El-Sadr Site(s) in Kenya Kisumu Impact Research and Development Organization (K-IRDO) CRS |
11-11-2021 |
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