Bedaquiline for preventing leprosy after exposure
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study
PHASE3 · Institute of Tropical Medicine, Belgium · NCT05597280
This study is testing if a new treatment called Bedaquiline can better prevent leprosy in people living close to someone who has the disease compared to the usual medication.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 124000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Institute of Tropical Medicine, Belgium (other) |
| Locations | 1 site (Moroni) |
| Trial ID | NCT05597280 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 years and older living within 100 meters of a confirmed leprosy case.
Not a fit: Patients with active leprosy or tuberculosis, or those who have recently received rifampicin or bedaquiline, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of leprosy in high-risk populations.
How similar studies have performed: While similar approaches have been explored, the use of BE-PEP specifically for leprosy prophylaxis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Moroni
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leprosy