Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Recruiting
Phase 3
Interventional Study
Leprosy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 2 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 124,000 (estimated)
- Sponsor
- Institute of Tropical Medicine, Belgium · Other
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About This Trial
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 targe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health
2. 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 w…
Contacts