drugset / Trial / NCT03662022
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Phase 3
Completed
144000 enrolled
Institute of Tropical Medicine, Belgium
Centre d'Infectiologie Charles Mérieux · collabDamien Foundation · collabFondation Raoul Follereau · collabGenoscreen · collabInstituto Fernandes Figueira · collabL'Institut National de la Santé et de la Recherche Médicale · collabLeiden University Medical Center · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a cluster randomized trial on effectiveness of different modalities of Single Double Dose of Rifampicin Post-Exposure Prophylaxis (SDDR-PEP) for leprosy in the Comoros (Anjouan and Mohéli) and Madagascar. The study aims to identify which approach to the selection of contacts for post exposure prophylaxis is most effective to reduce incident leprosy, and to Interrupt ongoing transmission from asymptomatic persons in the process of developing multibacillary leprosy.
Timeline
- Start
- 2019-01-02
- Primary completion
- 2023-01-17
- Completion
- 2023-01-17
Publications
- Hasker E, Assoumani Y, Randrianantoandro A, Ramboarina S, Braet SM, Cauchoix B, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Attoumani N, Grillone SH, Ronse M, Peeters Grietens K, Rakoto-Andrianarivelo M, Harinjatovo H, Supply P, Snijders R, Hoof C, Tsoumanis A, Suffys P, Rasamoelina T, Corstjens P, Ortuno-Gutierrez N, Geluk A, Cambau E, de Jong BC. Post-exposure prophylaxis in leprosy (PEOPLE): a cluster randomised trial. Lancet Glob Health. 2024 Jun;12(6):e1017-e1026. doi: 10.1016/S2214-109X(24)00062-7.
- Marijke Braet S, Jouet A, Aubry A, Van Dyck-Lippens M, Lenoir E, Assoumani Y, Baco A, Mzembaba A, Cambau E, Vasconcellos SEG, Rigouts L, Suffys PN, Hasker E, Supply P, de Jong BC. Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study. Lancet Microbe. 2022 Sep;3(9):e693-e700. doi: 10.1016/S2666-5247(22)00117-3. Epub 2022 Jul 15.
- Ortuno-Gutierrez N, Younoussa A, Randrianantoandro A, Braet S, Cauchoix B, Ramboarina S, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Richardus JH, de Jong BC, Hasker E. Protocol, rationale and design of PEOPLE (Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar): a cluster randomized trial on effectiveness of different modalities of implementation of post-exposure prophylaxis of leprosy contacts. BMC Infect Dis. 2019 Dec 5;19(1):1033. doi: 10.1186/s12879-019-4649-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rifampin | Small molecule | 20 mg/kg | — |