Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

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.

Conditions

• Leprosy

Interventions

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.

Sponsors & Collaborators

• Damien Foundation

  collaborator OTHER

• Centre d'Infectiologie Charles Mérieux

  collaborator OTHER

• Fondation Raoul Follereau

  collaborator UNKNOWN

• Leiden University Medical Center

  collaborator OTHER

• L'Institut National de la Santé et de la Recherche Médicale

  collaborator UNKNOWN

• Genoscreen

  collaborator OTHER

• Instituto Fernandes Figueira

  collaborator OTHER_GOV

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• Bouke de Jong, MD, PhD · Institute of Tropical Medicine

• Epco Hasker, MD · Institute of Tropical Medicine

• Younoussa Assoumani, MD · Damien Foundation

• Bertrand Cauchoix, MD · Fondation Raoul Follereau

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-02

Primary Completion

2023-01-17

Completion

2023-01-17

Countries

• Comoros
• Madagascar

Study Locations