At STOP2030 we want to provide a pharmacological tool that helps at delivering WHO's elimination goals for soil-transmitted helminthiasis (STH). That is why we're happy to announce that we've completed the design of the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness). The details of the trial have been published in clinicaltrials.gov and the Pan African Clinical Trial Registry, and are now ready to be delivered to the Institutional Review Boards (IRBs) in Ghana and Kenya, the two countries were it will be carried out.
At STOP2030 we want to provide a pharmacological tool that helps at delivering WHO's elimination goals for soil-transmitted helminthiasis (STH). That is why we're happy to announce that we've completed the design of the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness). The details of the trial have been published in clinicaltrials.gov and the Pan African Clinical Trial Registry, and are now ready to be delivered to the Institutional Review Boards (IRBs) in Ghana and Kenya, the two countries were it will be carried out.
The design of the clinical trial was lead by the teams at ISGlobal and Liconsa, with help from other members of our Consortium. It 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 design of the clinical trial was lead by the teams at ISGlobal and Liconsa, with help from other members of 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 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 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.
Borja Robert
10 months ago