Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
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.