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Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

NCT05597280 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124000

Last updated 2026-05-19

No results posted yet for this study

Summary

There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.

Conditions

  • Leprosy

Interventions

DRUG

BE-PEP Bedaquiline

bedaquiline

DRUG

SDR-PEP Rifampicin

SDR-PEP: rifampicin

DRUG

BE-PEP Rifampicin

BE-PEP rifampicin

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Younoussa Assoumani · Damien Foundation Comoros

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2027-03-15
Completion
2027-03-15

Countries

  • Comoros

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05597280 on ClinicalTrials.gov