Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.

NCT Number	NCT05597280
Lead Sponsor	Institute of Tropical Medicine, Belgium
Conditions	Leprosy
Enrollment	124,000 participants
Start Date	2023-03-22
Primary Completion	2027-03-15 (estimated)
Study Completion	2027-03-15 (estimated)
Updated on ClinicalTrials.gov	2026-05-19