Phase 3 N=94,127 Randomized Prevention

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Leprosy

Bottom Line

View on ClinicalTrials.gov: NCT03662022 ↗

Enrolled (actual)

94,127

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rifampicin (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Institute of Tropical Medicine, Belgium
Primary completion: Jan 2023

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03662022). 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.