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

StatusRecruiting
PhasePhase 3
Started
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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.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Aug 2025 to Apr 2026
    • Start date changed from estimate of Mar 2025 to Sep 1, 2025
    • Study completion date: Jul 2026 to Feb 2027
    • Site details revised at 2 of 2 sites
  2. Phase: Phase 4 to Phase 3v2 Show 7 more changesShow less
    • Start date: Oct 2024 to Mar 2025
    • Primary completion date: Feb 2026 to Aug 2025
    • Study completion date: Jun 2026 to Jul 2026
    • Eligibility criteria expanded, about 48 words
    • Site details revised at 2 of 2 sites
    • Collaborators revised (8)
    • Study description expanded, about 4 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Soil-Transmitted Helminths
Related terms Hookworm Infections
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov