Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study

BE-PEOPLE Phase 3

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.

2023-03-22

2026-12-31

2026-12-31

Recruiting

Early phase I

124000

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) 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 124000, 'type': 'ESTIMATED'}}

2023-09-14