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 range5 Years – 17 Years
SexALL
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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.
✕. 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.
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)