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Page 3 of 54, showing 5 Applications out of 267 total, starting on record 11, ending on 15

# Protocol No Study Title Investigator(s) & Site(s) Application Status

11.

ECCT/20/10/04   yellow fever vaccine CVIA 079
    A Phase III double-blind, randomized, active comparator controlled study in healthy Kenyan adolescents, young children and infants to assess the safety and immunogenicity of Beijing Institute of Biologic Products (BIBP) yellow fever vaccine in comparison to a WHO 17D-204 prequalified comparator yellow fever vaccine, as well as lot-to-lot consistency of immune response to the BIBP yellow fever vaccine”, CVIA 079.   
Principal Investigator(s)
1. Dr. Deborah Langat
Site(s) in Kenya
KEMRI/KERICHO CLINIC RESEARCH CENTRE
 
Trial Status Recruiting
Protocol Date 16-09-2020
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12.

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)
 
Trial Status (not set!)
Protocol Date 25-05-2021
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13.

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)
 
Trial Status (not set!)
Protocol Date 14-08-2020
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14.

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)
 
Trial Status Recruiting
Protocol Date 18-02-2020
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15.

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)
 
Trial Status (not set!)
Protocol Date 06-05-2020
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