Bedaquiline Enhanced Post-Exposure Prophylaxis for Leprosy: Phase 3 Randomized Study Comparing BE-PEP and Standard SDR-PEP

What this Trial Is About

Researchers are evaluating a new approach to prevent leprosy in people living near someone recently diagnosed with the disease. This phase 3 randomized study compares two treatments: a combination of bedaquiline and rifampicin (BE-PEP) versus the World Health Organization's standard single-dose rifampicin (SDR-PEP). The goal is to assess which method better reduces the risk of developing leprosy and lowers the overall number of cases over time. Participants will be assigned to one of two groups. In the intervention group, BE-PEP—bedaquiline at 400 or 800 mg depending on weight combined with rifampicin at 10 mg/kg—is given to individuals living within 100 meters of an index case, with a repeat dose after four weeks for household contacts. The comparison group receives the standard single dose of rifampicin at 10 mg/kg. If more than half the village is eligible, the entire village is included. Treatment delivery uses specific dosage forms of rifampicin and bedaquiline, and the study started providing BE-PEP in 2023, with follow-up planned through 2026. During the study, participants are monitored for leprosy development and possible side effects such as nausea, headache, dizziness, or skin reactions up to 30 days after treatment. Researchers collect skin biopsies from leprosy patients to check for drug resistance using molecular tests and monitor tuberculosis patients for similar resistance patterns. The main outcome measured is the rate of leprosy cases between the two groups over about four years, alongside a village-level impact assessment. The study aims to provide a safe and effective prevention strategy and support future national guideline updates.

Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy