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 used as the standard 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) program. to evaluate its safety as a primary endpoint, and its effectiveness profile as a secondary endpoint, in a large population of school-aged children.
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.
The clinical trial will have two arms, randomized by school. One arm will receive a single dose of the fixed-dose coformulation tablet (alb 400mg/ivm 9mg for children between 5 and 14 years old, alb 400mg/ivm 18mg for 15-17s), while the other, acting as an active control group, will receive a single dose of albendazole 400mg.
Borja Robert
10 months ago