Actively Recruiting
Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Led by Insud Pharma · Updated on 2025-09-15
20000
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
Sponsors
I
Insud Pharma
Lead Sponsor
G
Ghana Health Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 17 years old attending selected schools in Ghana and Kenya
- Height over 110 cm
- Written informed consent from parent or guardian
- Written assent from children aged 12 to 17 years as per local laws
You will not qualify if you...
- Recent travel to countries with risk of Loa loa infection: Angola, Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria, Sudan
- Serious medical illness such as high fever, severe diarrhea, or neurological symptoms
- Any condition preventing proper evaluation and follow-up
- Known allergy to any component of the study treatments
- Female participants who are pregnant or within one week postpartum; must have negative pregnancy test at screening
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ghana Health Service (GHS)
Accra, Accra, Ghana
Actively Recruiting
2
Kenya Medical Research Institution (KEMRI)
Nairobi, Nairobi County, Kenya, 00200
Actively Recruiting
Research Team
A
Alejandro J. Krolewiecki, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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