NCT05597280 Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
| NCT ID | NCT05597280 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institute of Tropical Medicine, Belgium |
| Condition | Leprosy |
| Study Type | INTERVENTIONAL |
| Enrollment | 124,000 participants |
| Start Date | 2023-03-22 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 124,000 participants in total. It began in 2023-03-22 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Younoussa Assoumani
PRINCIPAL INVESTIGATOR
Damien Foundation Comoros
Frequently Asked Questions
Who can join the NCT05597280 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Leprosy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05597280 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 124,000 participants.
Is NCT05597280 currently recruiting?
Yes, NCT05597280 is actively recruiting participants. Contact the research team at choof@itg.be for enrollment information.
Where is the NCT05597280 trial being conducted?
This trial is being conducted at Moroni, Comoros.
Who is sponsoring the NCT05597280 clinical trial?
NCT05597280 is sponsored by Institute of Tropical Medicine, Belgium. The principal investigator is Younoussa Assoumani at Damien Foundation Comoros. The trial plans to enroll 124,000 participants.