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New treatment option for Leprosy
Official title Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
ClinicalTrials.gov ID: NCT05597280
What this study is testing
What is BE-PEP Bedaquiline?
BE-PEP Bedaquiline is an investigational medicine, being studied as a potential treatment for leprosy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)
You likely can't join if
- Signs of active leprosy
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Moroni, Comoros
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moroni, Comoros. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.