Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This study will evaluate a combination of bedaquiline and rifampicin as post exposure
prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP
with rifampicin, which is ending in 2022. This new trial will be called the 'Bedaquiline
Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial. There will be two main
study arms, a comparator arm based on the current WHO recommendation of providing a single
dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm
in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight,
to be repeated once after four weeks for household contacts. The main study will be preceded
by a phase 2 safety study.