Clinical Trial

Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness

Recruiting Phase 3
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Record status
This record was last updated September 15, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-02-20; most recent amendment 2025-09-08.
Status change: Not Yet Recruiting → Recruiting 2025-09-08
Trial Details
NCT Number NCT06282315
Lead Sponsor Insud Pharma
Collaborators: Ghana Health Services, Kenya Medical Research Institute, Bridges to Development, Sanger Institute, Barcelona Institute for Global Health, European Union, Swiss Confederation, Fundación Mundo Sano
Conditions Soil-Transmitted Helminths
Enrollment 20,000 participants
Start Date 2025-09-01
Primary Completion 2026-04 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-15