From 75b4fc42f67fca2891a58c43aad9fa5d27f13df4 Mon Sep 17 00:00:00 2001 From: Borja Robert Date: Thu, 21 Mar 2024 14:15:00 +0100 Subject: [PATCH] Auto saved by Logseq --- pages/STOP2030___Web___Posts.md | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/pages/STOP2030___Web___Posts.md b/pages/STOP2030___Web___Posts.md index 2e5dbc92..8d45e49a 100644 --- a/pages/STOP2030___Web___Posts.md +++ b/pages/STOP2030___Web___Posts.md @@ -7,7 +7,7 @@ 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 a context of 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. 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.