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Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)

NCT05406479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2024-08-28

Study results available
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Summary

This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022. This new trial will be called the 'Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial. There will be two main study arms, a comparator arm based on the current WHO recommendation of providing a single dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight, to be repeated once after four weeks for household contacts. The main study will be preceded by a phase 2 safety study.

Conditions

  • Leprosy

Interventions

DRUG

BE-PEP (Bedaquiline)

Single dose of Bedaquiline

DRUG

SDR-PEP

Single dose of Rifampicin

DRUG

BE-PEP (Rifampicine)

Single dose of Rifampicin

Sponsors & Collaborators

  • Damien Foundation

    collaborator OTHER

  • 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
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2023-01-26
Completion
2023-01-26

Countries

  • Comoros

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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 NCT05406479 on ClinicalTrials.gov