Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 2 Study

BE-PEOPLE Phase 2

This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022. This new trial will be called the 'Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial. There will be two main study arms, a comparator arm based on the current WHO recommendation of providing a single dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight, to be repeated once after four weeks for household contacts. The main study will be preceded by a phase 2 safety study.

2022-07-14

2023-01-26

2023-01-26

Completed

Early phase I

321

Inclusion Criteria: 1. Being a permanent resident of the study village, in good state of health 2. Able and willing to provide informed consent 3. Age 5 years or above and weight of 20 kg or above 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. History of liver- or kidney disease 5. Allergy to rifampicin or bedaquiline 6. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period 7. Not able to swallow bedaquiline 100 mg tablets 8. Self-reported (suspected) pregnancy or breastfeeding 9. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only) 10. QT-prolongation of ≥450 msec in baseline ECG within the last week. 11. Jaundice or self-reported liver function abnormalities or hepatitis 12. Value of baseline ALT or AST \>3x ULN within the last week. In case only ALT is available, this would suffice for enrollment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 321, 'type': 'ACTUAL'}}

2023-06-12