Clinical Trial Applications: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | |
|---|---|---|---|---|
486. |
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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487. |
ECCT/23/10/08 | VALUE Placebo Film Study Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films (MATRIX-002) |
Principal Investigator(s) 1. Nelly Rwamba Mugo Site(s) in Kenya KEMRI-CCR PHRD Thika |
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488. |
ECCT/19/11/06 | Optimize LNG EC An Open Label Phase 2 Pharmarcokinetic Study to Evaluate Double - Dose Levonorgestrel Emergency Contraception in Combination withEfavirenz Based Antiretroviral Therapy or Rifampicin Containing Anti - Tuberculosis Therapy. A5375 |
Principal Investigator(s) 1. Lucy Chepkurui Koech Site(s) in Kenya KEMRI/WRP Kericho |
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489. |
ECCT/21/03/06 | P2026 Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum |
Principal Investigator(s) 1. Dr. Lucy Chepkurui Koech Site(s) in Kenya KENYA MEDICAL RESEARCH INSTITUTE/WALTER REED PROJECT CLINICAL RESEARCH CENTER |
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490. |
ECCT/13/04/09 | Short-course RPT/INH for latent TB in HIV-infected individuals 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. 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) |
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