The details of the REALISE study have been published in ClinicalTrials.gov and the Pan African Clinical Trial Registry. These details will soon be shared with the Institutional Review Boards (IRBs) in Ghana and Kenya, the two countries where patient recruitment and treatment administration will take place.
The design of the clinical trial was lead by the teams at ISGlobal and Liconsa, with support from GHS (Ghana Health Service) and KEMRI (Kenya Medical Research Institute), as well help from other members of our Consortium.
The design of this clinical trial was lead by the teams at ISGlobal and Liconsa, with support from GHS (Ghana Health Service) and KEMRI (Kenya Medical Research Institute) and other partners in our Consortium.
The study itself is a Cohort Event Study aimed at evaluating the safety and effectiveness of our fixed-dose coformulation (FDC) of albendazol and ivermectin within large populations, matched against the standard dose albendazole currently in use against STH. We expect to recruit around 20 thousand school-aged children between 5 and 17 years old between the two countries.
The study itself is a Cohort Event Study aimed at evaluating the safety and effectiveness of our fixed-dose coformulation (FDC) of albendazol and ivermectin within large populations. It will be matched against the standard dose albendazole currently in use against STH. We expect to recruit around 20 thousand school-aged children between 5 and 17 years old between the two countries.
The general objectives of the REALISE study are to validate the benefits of the FDC through this pragmatic trial, in the context of a mass drug administration (MDA) programme, to evaluate its safety as a primary endpoint, and its effectiveness profile as a secondary endpoint, in a large population of school-aged children.
Borja Robert
10 months ago