Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness (NCT06282315) | Clinical Trial Compass
RecruitingPhase 3
Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Ghana, Kenya20,000 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
5 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 5 to 17 years old (included).
. Height: over 110 cm.
. Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation (12-17 years old).
Exclusion criteria
. Epidemiological risk of being infected by Loa loa, defined as those who have visited any of the following countries: Angola, Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan.
. Serious medical illness, defined as participants showing symptoms of acute illness which could hamper the participation in the trial, such as high-grade fever, severe diarrhoea, neurological symptoms or others, per investigator's criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a new combination pill of albendazole and ivermectin to albendazole alone for soil-transmitted helminths — can you help me understand what having two active drugs together might mean for my side effect risk compared to taking albendazole by itself?
2Since the main thing this Phase 3 trial is measuring is adverse events and serious adverse events, does that mean there's still some uncertainty about the safety profile of this combination treatment, and how does that factor into your recommendation for me?
3This is a real-world study, so it sounds like it's being done outside of a strictly controlled lab setting — can you explain what that means for how reliable the safety data will be and whether that changes anything about the risk I'd be taking?
4Is albendazole alone — which is the comparison treatment in this trial — already an established standard of care for my situation, and would it make more sense for me to just receive that proven treatment rather than participating in a study?
5Given that this trial is currently recruiting, what would my actual day-to-day participation look like — how many visits, what kind of monitoring, and how closely would my symptoms and side effects be tracked throughout?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AEs and SAEs record of participants treated with FDC compared to ALB.
Timeframe: 7 days, active surveillance (Day 0 (1 hour), Day 1, Day 2 and Day 7 post-intervention) and passive surveillance (From Day 0 up to Day 6 post-intervention)