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Completed

NCT Number: NCT03662022

Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

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.

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Key information

Conditions

Leprosy Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Damien Foundation, Anjouan, Comoros

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About this study

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:

  • No Post-Exposure Prophylaxis (PEP) is given to anyone
  • PEP is given to all household contacts of incident leprosy cases
  • PEP is given to all people who live in a 100m radius of incident leprosy cases
  • 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rifampicin

Drug

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.

Primary outcomes

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

    Time frame: 45 months

    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.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • 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

Registry information

Acronym: PEOPLE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2018
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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