Bedaquiline for preventing leprosy after exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of Bedaquiline Enhanced Post Exposure Prophylaxis (BE-PEP) compared to the standard WHO recommended prophylaxis for leprosy. Participants living within 100 meters of an index case will be randomly assigned to receive either BE-PEP or standard rifampicin treatment. The study aims to assess the incidence of leprosy in both groups over a follow-up period from 2023 to 2026. The primary outcome will be the comparison of leprosy risk between the two arms, with additional analysis of overall leprosy incidence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health
2. Aged 2 years and above, as leprosy is very rare among infants and young toddlers. Children age 2-4 years or weighing less than 20 kg will not be given bedaquiline. If eligible they will receive only rifampicin.
3. Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)

Exclusion Criteria:

1. Signs of active leprosy
2. Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)
3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
4. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
5. Self-reported (suspected) pregnancy or breastfeeding
6. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)

Where it's running

• Fondation Damien
  Moroni, Comoros Recruiting

Study contacts

• Principal investigator: Younoussa Assoumani — Damien Foundation Comoros
• Study coordinator: Carolien Hoof
• Email: choof@itg.be
• Phone: +32(0)32470716

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.