Status:
COMPLETED
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Damien Foundation
Conditions:
Leprosy
Eligibility:
All Genders
5+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Given the fact that the investigators are going to provide to healthy people a drug that has not been used before for this indication and which has only been conditionally approved for use in multi-dr...
Eligibility Criteria
Inclusion
- 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
- 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
- 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)
- QT-prolongation of ≥450 msec in baseline ECG within the last week.
- Jaundice or self-reported liver function abnormalities or hepatitis
- Value of baseline ALT or AST \>3x ULN within the last week. In case only ALT is available, this would suffice for enrollment
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2023
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT05406479
Start Date
July 14 2022
End Date
January 26 2023
Last Update
August 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondation Damien
Gege, Ndzuwani, Comoros