Clinical Trial Applications: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | |
|---|---|---|---|---|
251. |
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) |
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252. |
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 |
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253. |
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 |
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254. |
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) |
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255. |
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) |
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