NCT03662022

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144,000 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Detailed description

For the purpose of the study, villages on the Comoros and Madagascar that will be randomly assigned to one of the study arms, will be screened on a yearly basis for 4 consecutive years. Depending on which of the 4 arms a village is assigned to, people in the surroundings of a leprosy patient will or will not be offered Post-Exposure Prophylaxis (PEP) using rifampicin at 20mg/kg single dose: 1. No Post-Exposure Prophylaxis (PEP) is given to anyone 2. PEP is given to all household contacts of incident leprosy cases 3. PEP is given to all people who live in a 100m radius of incident leprosy cases 4. PEP is given to all household contacts of incident leprosy cases as well as to all others who live within a 100m radius of an incident leprosy case and test positive in the UCP-LFA detecting anti-M. leprae PGL-I IgM antibodies (Ab) in fingerstick blood (anti-PGL-1)

Conditions

• Leprosy

Interventions

Type	Name	Description
DRUG	Rifampicin	Rifampicin will be given in the same way to arms 2, 3 and 4 (weight dependent). Only the strategy of whom to offer PEP differs between the arms.

Timeline

• Start date: 2019-01-02
• Primary completion: 2023-01-17
• Completion: 2023-01-17
• First posted: 2018-09-07
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

3 sites across 2 countries: Comoros, Madagascar