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

BOHEMIA

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 WHO´s preferred product characteristics (PPC) for endectocides.

2022-03-17

2024-04-16

2024-10-31

Active (not recruiting)

Early phase I

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 cross sectionals: * Residents of the area for at least 3 months prior to enrolment * Parent/guardian's consent for minors * Ability to provide assent for minors aged 12 to 17 * Written consent from adults 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 For cross sectionals: • Non-residents 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 (28 days after dosing) * Calves under 8 weeks and piglets under 6 weeks of age

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The BOHEMIA trials are open-label with random assignment to one of 3 treatment arms in Mozambique and 2 in Kenya: (a) ivermectin in humans, (b) ivermectin in humans + livestock (only in Mozambique), or (c) albendazole control.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label, assessor-blinded'}}, 'enrollmentInfo': {'count': 53000, 'type': 'ESTIMATED'}}

2024-06-03