Clinical Trial Applications: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | |
|---|---|---|---|---|
221. |
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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222. |
ECCT/20/09/06 | Schisto RDT evaluation A performance evaluation of a prototype rapid diagnostic test for the diagnosis of schistosomiasis |
Principal Investigator(s) 1. Sammy Njenga Site(s) in Kenya Kenya Medical Research Institute (KEMRI) |
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223. |
ECCT/20/09/04 | Pharmacy PrEP Delivery Pharmacy delivery to expand the reach of PrEP in Kenya: Pilot Study |
Principal Investigator(s) 1. Prof. Elizabeth Bukusi Site(s) in Kenya 1. PHRDTHIKA (Kiambu county) 2. Kisumu Site (Kisumu county) |
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224. |
ECCT/20/10/01 | HIV-CORE 006 A Phase 1 Trial of ChAdOx1- and MVA-vectored Conserved Mosaic HIV-1 Vaccines in Healthy, Adult HIV-1-negative Volunteers in Eastern and Southern Africa. |
Principal Investigator(s) 1. Eduard J Sanders Site(s) in Kenya 1. KEMRI Mtwapa Research Clinic (Kilifi county) 2. KAVI-ICR Nairobi (Nairobi City county) |
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225. |
ECCT/20/09/02 | BEe-HIVe B-ENHANCEMENT OF HBV VACCINATIONIN PERSONS LIVING WITH HIV (BEe-HIVe) EVALUATION OF HEPLISAV-B,A5379 |
Principal Investigator(s) 1. JOSPHAT KOSGEI Site(s) in Kenya KEMRI/KERICHO CLINIC RESEARCH CENTRE |
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