At STOP2030 we want to provide a pharmacological tool that helps at delivering WHO's goals for soil-transmitted helminthiasis (STH). That is why we're happy to announce that the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness), an ambitious clinical trial, has been approved for publication in clinicaltrials.gov and the Pan African Clinical Trial Registry.
This clinical trial 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 in Kenya and Ghana.
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 the safety as a primary endpoint and 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.
