Broad One Health Endectocide-based Malaria Intervention in Africa - BOHEMIA: A Phase III cluster-randomized, open-label, clinical trial to study the safety and efficacy of ivermectin mass drug administration to reduce malaria transmission in two African settings.

Phase 3

• Conditions: Malaria

• Registration Number: PACTR202106695877303
• Lead Sponsor: Barcelona Institute for GlobalHealth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 53000

Inclusion Criteria

For human treatment/safety cohort
•Residents of the study area
•Male or female weighing more than 15kg
•Adult able to provide written consent
•Minors aged 12 to 17 able to provide assent
•Parent/guardian’s able to provide consent for minors
•Negative pregnancy test for women aged between 13 and 49
•Agreement to adhere to study visits and procedures
For pediatric active cohort:
•Children in the age of highest burden at the time of enrollment (under 5 years of age in Mozambique or 5-15 in Kenya)
•Residents of the study area
•Parent/guardian’s able to provide consent for minors
•Minors aged 12 to 15 in Kenya able to provide assent
For livestock treatment:
•Owner/guardian able to provide consent
•Animal expected to spend at least one week every study month inside the cluster border

Exclusion Criteria

For human treatment/safety cohort:
•Known hypersensitivity to ivermectin or albendazole
•Risk of Loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria or Sudan
•Pregnant women
•Lactating women in the first week postpartum
•Children < 15 kg
•Currently participating in another clinical trial
•Unwilling to provide informed consent or assent
•Unwilling to adhere to study visits and/or procedures
•Severely ill either self-reported or in the eyes of the investigator, e.g. defined as need for clinical care, or active or progressive disease interfering with activities of daily living. If in doubt, these criteria can be confirmed after a call with either the site PI/MD/safety officer against a pre-defined list.
•Currently under treatment with inhibitors of CYP3A or P-gp or other drugs that can interfere with the study
For incidence cohort:
•Non-residents
•Currently enrolled in other clinical trial
5.2.4. For livestock treatment
•Received ivermectin three weeks than four weeks ago
•Intention to milk or slaughter the animal for human consumption during the withdrawal period
•Calves under 8 weeks and piglets under 6 weeks of age

Study & Design

• Study Type: Interventional
• Study Design: Not specified