Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (BE-PEOPLE P3)
Leprosy
About this trial
This is an interventional prevention trial for Leprosy
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)
- 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)
Sites / Locations
- Fondation DamienRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BE-PEP
SDR PEP
Intervention arm in which BE-PEP will be provided to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. BE-PEP: bedaquiline (400 or 800 mg depending on weight band) combined with rifampicin (10 mg/kg) will be provided as post-exposure prophylaxis Both arms will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg, for bedaquiline it's 20 mg or 100 mg.
WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms anyone living within 100 meters of an index case will be targeted or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg.