Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2) (NCT05406479) | Clinical Trial Compass
CompletedPhase 2
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)
Comoros313 participantsStarted 2022-07-14
Plain-language summary
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.
Who can participate
Age range5 Years
SexALL
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Inclusion criteria
✓. Being a permanent resident of the study village, in good state of health
✓. Able and willing to provide informed consent
✓. Age 5 years or above and weight of 20 kg or above
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)
✕. History of liver- or kidney disease
✕. Allergy to rifampicin or bedaquiline
✕. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
✕. Not able to swallow bedaquiline 100 mg tablets
✕
What they're measuring
1
Mean Difference in QTc Interval Between the Two Arms 24 Hours After Treatment Administration
Timeframe: 24 hours after treatment administration
2
Occurence of Any Predetermined Study Stopping Criteria, Which Will Trigger an Immediate Pause on Enrollment
Timeframe: Until day 30 after treatment administration