Clinical Trial Applications: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | |
|---|---|---|---|---|
206. |
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) |
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207. |
ECCT/20/11/05 | HOPE Kids 2 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Voxelotor (GBT440) in Pediatric Participants with Sickle Cell Disease (HOPE Kids 2) |
Principal Investigator(s) 1. Jessie Nyokabi Githanga 2. Videlis Nduba 3. Bernhards Ragama Ogutu Site(s) in Kenya 1. Gertrude’s Children’s Hospital (Nairobi City county) 2. KEMRI/CRDR Clinical Research Annex (Nairobi City county) 3. Strathmore University Medical Centre (Nairobi City county) 4. KEMRI/CRDR Siaya (Siaya county) |
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208. |
ECCT/20/11/04 | FAST Study Assessments of the EFficacy, the onset-of-Action and the Safety of Tot'héma® in adults with moderate iron deficiency anaemia |
Principal Investigator(s) 1. Naftali Wasindi Busakhala 2. Otieno Odhiambo Fredrick Site(s) in Kenya 1. MOI University Teaching and Referral Hospita (Nandi county) 2. UNIM Research and Training Centre (Kisumu county) 3. Kenyatta National Hospital (Nairobi City county) |
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209. |
ECCT/20/11/03 | IMR-SCD-301 A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease |
Principal Investigator(s) 1. Jessie Nyokabi Githanga 2. Videlis Nduba Site(s) in Kenya 1. Kenya Medical Research Institute-Kondele Children\'s Hospital (Kisumu county) 2. The Center For Respiratory Disease Research/KEMRI (Nairobi City county) 3. Gertrude\'s Children\'s Hospital (Nairobi City county) |
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210. |
ECCT/20/11/02 | IAVI C100 Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults (IAVI C100) |
Principal Investigator(s) 1. Nelly Mugo Site(s) in Kenya 1. Partners in Health Research and Development (PHRD) – CCR-KEMRI (Kiambu county) 2. Kenya AIDS Vaccine Initiative- Institute of Clinical Research (KAVI-ICR) (Nairobi City county) |
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