Phase 3
Completed N=94,127
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Source: ClinicalTrials.gov NCT03662022 ↗Enrolled (actual)
94,127
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis — 1.04; 1.42; 0.98; 0.92 number of new cases per 1000 person/year — p=<0.017
◆ Published Evidence
Established
31citations · ~4 / year
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.
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.
Linked Publications (3)
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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.
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Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study.
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Post-exposure prophylaxis in leprosy (PEOPLE): a cluster randomised trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis |
1.04; 1.42; 0.98; 0.92 | <0.017 sig |
Eligibility Criteria
Inclusion Criteria
- Living in one of the study villages
- Aged 2 years and above
- Able and willing to provide informed consent
Exclusion Criteria
- Signs of active leprosy (*)
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration) (*)
- Having received Rifampicin within the last 24 months (*)
(*) These people may still be included for yearly leprosy screening, but will be excluded to receive PEP
Data sourced from ClinicalTrials.gov (NCT03662022) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.