Clinical Trial Applications: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | |
|---|---|---|---|---|
266. |
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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267. |
ECCT/20/12/02 | MERS-201 Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers |
Principal Investigator(s) 1. Bernhards Ogutu 2. Josphat Kosgei Site(s) in Kenya 1. Ahero Clinical Trials Unit (Kisumu county) 2. Kenya Medical Research Institute/Walter Reed Project (KEMRI/WRP) (Kericho county) |
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268. |
ECCT/20/12/03 | CALINA STUDY A multicenter, open-label, single-arm study to evaluate the PK, safety, tolerability and efficacy of a new artemether-lumefantrine (2.5 mg:30 mg) dispersible tablet in the treatment of infants and neonates <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria. Study number: CCOA566B2307 |
Principal Investigator(s) 1. Benhards Ragama Ogutu Site(s) in Kenya KEMRI-Centre for Clinical Research (CCR) |
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269. |
ECCT/21/02/01 | PTSD 102 TONIX A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants with PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P308). |
Principal Investigator(s) 1. Prof. Lukoye Atwoli Site(s) in Kenya 1. Moi Teaching and Referral Hospital/Moi University (Uasin Gishu county) 2. KEMRI Nairobi (Nairobi City county) 3. Aga Khan University Hospital (Nairobi City county) |
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270. |
ECCT/21/02/02 | RESHAPE PROSPECTIVE NON-INTERVENTIONAL MULTI-CENTER STUDY EVALUATING BLEEDING INCIDENCE AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH HEMOPHILIA A WITH INHIBITORS AND NON-INHIBITORS TREATED WITH EMICIZUMAB AND OTHER HEMOPHILIA TREATMENTS IN A REAL-LIFE SETTING |
Principal Investigator(s) 1. Festus Njuguna Site(s) in Kenya Moi Teaching and Referral Hospital |
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