Moroni

Researchers are investigating the effectiveness of a new preventive treatment called BE-PEP, which combines rifampicin and bedaquiline, in reducing the risk of leprosy among people who live near new leprosy cases. This phase 3 study compares BE-PEP with the World Health Organization's standard single-dose rifampicin treatment. The goal is to find a safe and effective way to prevent leprosy and reduce its spread within communities on the islands of Comoros. The study has two groups: one receives BE-PEP, where all people living within 100 meters of a new leprosy case get the treatment, with household contacts receiving a second dose after four weeks; the other group receives the standard single-dose rifampicin as recommended by WHO. The treatment starts in 2023 and continues through 2026. The study targets villages where at least half the residents are eligible, aiming for wide coverage of those living near leprosy cases. Participants will be followed for about four years to compare leprosy rates between the two groups. Researchers will collect skin biopsies from leprosy patients to monitor bacteria and resistance to the drugs used. Tuberculosis patients will also be studied to check for drug resistance. The study includes monitoring health, screening for leprosy and tuberculosis, and tracking treatment safety and effectiveness to help inform future leprosy prevention guidelines in Comoros.