At a glance
ClinicalIndex Comparison Record- ✓Resident of study clusters on Anjouan or Mohéli islands
- ✓Age 2 years and above
- ✓Good health status
- ✓Able and willing to provide informed consent for screening and PEP administration
- ✕Signs of active leprosy
- ✕Signs of active pulmonary tuberculosis (cough ≥2 weeks without negative TB test)
- ✕Signs of active extra-pulmonary tuberculosis (nodules, lymph node/bone/joint involvement, cervical glands with discharge)
- ✕Rifampicin or bedaquiline use in past 2 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study
In Brief
A Phase 3 clinical trial evaluating BE-PEP Bedaquiline, SDR-PEP Rifampicin, and 1 other intervention for Leprosy. Currently recruiting, targeting 124,000 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
bedaquiline
SDR-PEP: rifampicin
BE-PEP rifampicin