drugset / Trial / NCT04966702

Broad One Health Endectocide-based Malaria Intervention in Africa (BOHEMIA)

NCT04966702

Phase 3 Completed 48145 enrolled Barcelona Institute for Global Health UNITAID · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The BOHEMIA program consists of a combination of studies organized around a central community prevention mass drug administration protocol and four sub-studies (i.e.; social science, entomology, health economics, and environmental), each written as an individual protocol. The protocol is central but used in two separate, individually powered trials in Mozambique and Kenya. The trials have been powered on the efficacy outcome and designed to meet the requirements of World Health Organization's (WHO) preferred product characteristics (PPC) for endectocides.

Timeline

Start
2022-03-17
Primary completion
2024-04-15
Completion
2024-10-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Albendazole Small molecule 400 mg Oral
Subject Ivermectin Small molecule 200 ug/kg Oral
Subject Ivermectin Small molecule 400 ug/kg Oral

Indications