Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

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.

Timeline

Start

2023-03-22

Primary completion

2027-03-15

Completion

2027-03-15

Publications

• Younoussa A, Samidine SN, Bergeman AT, Piubello A, Attoumani N, Grillone SH, Braet SM, Tsoumanis A, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Snijders R, Corstjens P, Ortuno-Gutierrez N, Hoof C, Geluk A, de Jong BC, Hasker E. Protocol, rationale and design of BE-PEOPLE (Bedaquiline enhanced exposure prophylaxis for LEprosy in the Comoros): a cluster randomized trial on effectiveness of rifampicin and bedaquiline as post-exposure prophylaxis of leprosy contacts. BMC Infect Dis. 2023 May 9;23(1):310. doi: 10.1186/s12879-023-08290-0.

Drugs

Indications