At a glance
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Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 2 Study
In Brief
A Phase 2 clinical trial evaluating BE-PEP (Bedaquiline), SDR-PEP, and 1 other intervention for Leprosy. Completed, enrolled 313 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Single dose of Bedaquiline
Single dose of Rifampicin
Single dose of Rifampicin