Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

Phase 3CompletedNCT03662022

Institute of Tropical Medicine, Belgium144,000 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

144,000

Conditions

Leprosy

Interventions

RifampicinDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Damien Foundation

Anjouan, Comoros

Damien Foundation

Mohéli, Comoros

Fondation Raoul Follereau

Miandrivazo, Menabe Region, Madagascar

Outcomes

Primary Outcomes

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

leprosy number of new cases per 1000 person years is reported. Incident cases were cases newly diagnosed while under follow-up. In the statisical analysis table: three incidence rate ratios between the comparator arm (arm 1) and each of the three intervention arms. These ratios will be based on incidence rates measured between the first and fourth household survey in each of the intervention arms, always divided by that of the comparator arm. Please note that accross the years a part of the same participants are revisited again, which might explain discrepancies in the overall number of participants analyzed.

Time frame: 45 months

Data from ClinicalTrials.gov

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