Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar

NCT03662022 | Completed Phase 3 Results

• 1 other identifier: 1248/18
• Study Type: interventional
• Target: 144,000
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  45 months

Study Arms (4)

No PEP

NO INTERVENTION

No PEP will be distributed

Household PEP

OTHER

PEP will be given to all household contacts of an incident leprosy patient

Drug: Rifampicin

PEP 100m

EXPERIMENTAL

PEP will be given to all household contacts of leprosy patients and to all other people living within a 100m radius of an incident leprosy patient.

Drug: Rifampicin

PEP 100m + positive for anti-PGL-I IgM Ab

OTHER

PEP will be given to all household contacts of leprosy patients and to all other people living within a 100m radius of an incident leprosy patient who test positive in the UCP-LFA detecting anti-M. leprae PGL-I IgM Ab in fingerstick blood (anti-PGL-I)

Drug: Rifampicin

Interventions

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.

Household PEP; PEP 100m; PEP 100m + positive for anti-PGL-I IgM Ab

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in one of the study villages
• Aged 2 years and above
• Able and willing to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Damien Foundation

Anjouan, Comoros

Location

Damien Foundation

Mohéli, Comoros

Location

Fondation Raoul Follereau

Miandrivazo, Menabe Region, Madagascar

Location

Related Publications (3)

• Hasker E, Assoumani Y, Randrianantoandro A, Ramboarina S, Braet SM, Cauchoix B, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Attoumani N, Grillone SH, Ronse M, Peeters Grietens K, Rakoto-Andrianarivelo M, Harinjatovo H, Supply P, Snijders R, Hoof C, Tsoumanis A, Suffys P, Rasamoelina T, Corstjens P, Ortuno-Gutierrez N, Geluk A, Cambau E, de Jong BC. Post-exposure prophylaxis in leprosy (PEOPLE): a cluster randomised trial. Lancet Glob Health. 2024 Jun;12(6):e1017-e1026. doi: 10.1016/S2214-109X(24)00062-7.

  PMID: 38762282 DERIVED

• Marijke Braet S, Jouet A, Aubry A, Van Dyck-Lippens M, Lenoir E, Assoumani Y, Baco A, Mzembaba A, Cambau E, Vasconcellos SEG, Rigouts L, Suffys PN, Hasker E, Supply P, de Jong BC. Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study. Lancet Microbe. 2022 Sep;3(9):e693-e700. doi: 10.1016/S2666-5247(22)00117-3. Epub 2022 Jul 15.

  PMID: 35850123 DERIVED

• Ortuno-Gutierrez N, Younoussa A, Randrianantoandro A, Braet S, Cauchoix B, Ramboarina S, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Richardus JH, de Jong BC, Hasker E. Protocol, rationale and design of PEOPLE (Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar): a cluster randomized trial on effectiveness of different modalities of implementation of post-exposure prophylaxis of leprosy contacts. BMC Infect Dis. 2019 Dec 5;19(1):1033. doi: 10.1186/s12879-019-4649-0.

  PMID: 31805862 DERIVED

MeSH Terms

Conditions

Leprosy

Interventions

Rifampin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Carolien Hoof
• Organization: Insitute of Tropical Medicine

choof@itg.be

+32470102562

Study Officials

• Bouke de Jong, MD, PhD

  Institute of Tropical Medicine

  STUDY CHAIR

• Epco Hasker, MD

  Institute of Tropical Medicine

  STUDY DIRECTOR

• Younoussa Assoumani, MD

  Damien Foundation

  PRINCIPAL INVESTIGATOR

• Bertrand Cauchoix, MD

  Fondation Raoul Follereau

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster randomized trial in which villages are assigned to one of four intervention groups

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: January 2, 2019
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CO (2); MA (1)