Actively Recruiting
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Led by Institute of Tropical Medicine, Belgium · Updated on 2024-06-28
124000
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living in one of the study clusters on the islands of Anjouan or Mohéli and in good health
- Aged 2 years or older
- Children aged 2 to 4 years or weighing less than 20 kg will receive only rifampicin, not bedaquiline
- Able and willing to provide informed consent for leprosy and tuberculosis screening and preventive treatment
You will not qualify if you...
- Having signs of active leprosy
- Showing signs of active pulmonary tuberculosis (cough lasting 2 weeks or more without a negative TB test)
- Showing signs of active extra-pulmonary tuberculosis (bluish-red nodules on lymph nodes, bones, joints, or cervical glands with discharge)
- Having received rifampicin or bedaquiline in the past 2 years
- Being pregnant or breastfeeding
- Using medications not listed as safe for bedaquiline within the last 3 weeks before starting treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondation Damien
Moroni, Comoros
Actively Recruiting
Research Team
C
Carolien Hoof
CONTACT
N
Natacha Herssens
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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