CompletedPhase 3

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Comoros, Madagascar144,000 participantsStarted 2019-01-02

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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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

What they're measuring

Compare Effectiveness in Curbing Transmission of Leprosy of Three Different Approaches of Post Exposure Prophylaxis

Timeframe: 45 months

Trial details

NCT IDNCT03662022

SponsorInstitute of Tropical Medicine, Belgium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-17

Results submitted2023-09-13

View on ClinicalTrials.gov More Leprosy trials