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

Recruiting now · Phase 3

Conditions studied: Soil-Transmitted Helminths

In brief

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.

Key facts

Study ID

NCT06282315

Run by

Insud Pharma

People needed

20000

Starts

2025-09-01

Expected to finish

2027-02-01

Last updated by the study team

2025-09-15

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Individuals of both sexes that attend the selected schools in the trial areas in Ghana and Kenya that meet the following 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).

You may not qualify if…

• 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.
• Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator's criteria.
• Known hypersensitivity to any component of either study treatment.
• Pregnant or first week post-partum: female participants who are post-menarche must have a negative urine pregnancy test at screening.

Where it is running

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

Full record on ClinicalTrials.gov

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