Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

• Status: Active, not recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: Centre d'Infectiologie Charles Mérieux; Centre d’Infectiologie Charles Mérieux; Damien Foundation; Fondation Raoul Follereau; Genoscreen; Instituto Fernandes Figueira; L'Institut National de la Santé et de la Recherche Médicale; Leiden University Medical Center
• Treatments: Rifampin

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