Single-dose combined albendazole‑ivermectin pill for treating intestinal worms in schoolchildren

A Pragmatic Phase III Multicentre Clinical Trial to Evaluate the Safety and Effectiveness of a Single Dose of an Albendazole-Ivermectin Coformulation vs Albendazole for Preventive Chemotherapy of Soil-Transmitted Helminth Infections in School-Aged Children

This will test whether a single combined albendazole‑ivermectin pill is safe and works better than standard albendazole for treating school-aged children (5–17 years) with intestinal worms during mass drug campaigns in Ghana and Kenya.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20000 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: Insud Pharma (Industry-sponsored)
• Locations: 2 sites (Accra, Accra and 1 other locations)
• Trial ID: NCT06282315 on ClinicalTrials.gov

What this trial studies

REALISE is an open-label, school-randomized, two-arm pragmatic Phase 3 trial in Ghana and Kenya that compares a fixed-dose combination albendazole‑ivermectin tablet to standard albendazole given as a single dose during mass drug administration. Approximately 20,000 children comprise the safety cohort (about 10,000 per country, 5,000 per arm) and an effectiveness cohort of about 4,500 children will have parasitological outcomes measured. Randomization occurs at the school level so all eligible children in a school receive the same assigned treatment, and dosing is age-based (5–14 years receive the lower ivermectin dose; 15–17 years receive the higher ivermectin dose coformulated with 400 mg albendazole). The primary endpoint is safety in the MDA context, with parasitological cure and infection reduction as secondary effectiveness endpoints.

Who should consider this trial

Good fit: School-attending children aged 5–17 years who are taller than 110 cm, whose parent/guardian provides written consent (and who provide assent where required), at participating schools in the Ghana and Kenya trial sites.

Not a fit: Children outside the 5–17 age range, those under 110 cm, those with recent travel to Loa loa–endemic countries, or with serious acute illness are excluded and unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, a single fixed-dose combination pill could improve cure rates against multiple worm species and simplify mass drug administration for schoolchildren, making programs more efficient.

How similar studies have performed: Previous research suggests combining albendazole and ivermectin can increase efficacy against certain soil-transmitted helminths, but large-scale fixed-dose coformulation use during mass drug administration remains relatively novel and is being tested here.

Eligibility criteria

Inclusion Criteria:

Individuals of both sexes that attend the selected schools in the trial areas in Ghana and Kenya that meet the following criteria:

1. Age: 5 to 17 years old (included).
2. Height: over 110 cm.
3. 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:
4. 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.
5. 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.
6. Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator's criteria.
7. Known hypersensitivity to any component of either study treatment.
8. Pregnant or first week post-partum: female participants who are post-menarche must have a negative urine pregnancy test at screening.

Where this trial is running

Accra, Accra and 1 other locations

• Ghana Health Service (GHS) — Accra, Accra, Ghana (Recruiting)
• Kenya Medical Research Institution (KEMRI) — Nairobi, Nairobi County, Kenya (Recruiting)

Study contacts

• Principal investigator: Alejandro Krolewiecki, MD — Insud Pharma
• Study coordinator: Alejandro J. Krolewiecki, MD

Conditions Soil-Transmitted Helminths; STH; albendazole; ivermectin; hookworms