Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)

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.

Timeline

Start

2022-07-14

Primary completion

2023-01-26

Completion

2023-01-26

Outcome

Met primary endpoint

paper Adjusting for baseline QTc, the regression coefficient and 95% CI (3.3; -1.4, 8.0) met the 10 ms non-inferiority margin. PMID 39432509 ↗

Publications

• de Jong BC, Nourdine S, Bergeman AT, Salim Z, Grillone SH, Braet SM, Wirdane Abdou M, Snijders R, Ronse M, Hoof C, Tsoumanis A, Ortuno-Gutierrez N, der Werf CV, Piubello A, Mzembaba A, Assoumani Y, Hasker E. Safety of single-dose bedaquiline combined with rifampicin for leprosy post-exposure prophylaxis: A Phase 2 randomized non-inferiority trial in the Comoros Islands. PLoS Med. 2024 Oct 21;21(10):e1004453. doi: 10.1371/journal.pmed.1004453. eCollection 2024 Oct.

Drugs

Indications