Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Status:
RECRUITING
Trial end date:
2027-02-01
Target enrollment:
Participant gender:
Summary
An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of 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.
Phase:
PHASE3
Details
Lead Sponsor:
Insud Pharma
Collaborators:
Barcelona Institute for Global Health Bridges to Development European Union Fundación Mundo Sano Ghana Health Services Kenya Medical Research Institute Sanger Institute Swiss Confederation
Treatments:
Mass Drug Administration Random Allocation Watchful Waiting