Status:
RECRUITING
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Conditions:
Leprosy
Eligibility:
All Genders
2+ years
Phase:
PHASE3
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 ...
Detailed Description
Assuming the phase 2 study will not reveal any drug related adverse events and following the advice of the DSMB and the involved ethics committees, the investigators will proceed with a phase 3 study ...
Eligibility Criteria
Inclusion Criteria:
- Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health
- 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.
- Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)
Exclusion Criteria:
- Signs of active leprosy
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)
- Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
- Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
- Self-reported (suspected) pregnancy or breastfeeding
- Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)
Key Trial Info
Start Date :
March 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
124000 Patients enrolled
Trial Details
Trial ID
NCT05597280
Start Date
March 22 2023
End Date
December 31 2026
Last Update
June 28 2024
Active Locations (1)
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1
Fondation Damien
Moroni, Comoros