Status:

RECRUITING

Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

Lead Sponsor:

Institute of Tropical Medicine, Belgium

Conditions:

Leprosy

Eligibility:

All Genders

2+ years

Phase:

PHASE3

Brief Summary

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 ...

Detailed Description

Assuming the phase 2 study will not reveal any drug related adverse events and following the advice of the DSMB and the involved ethics committees, the investigators will proceed with a phase 3 study ...

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 will receive only rifampicin.
  3. Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)

Exclusion Criteria:

  1. Signs of active leprosy
  2. Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)
  3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
  4. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
  5. Self-reported (suspected) pregnancy or breastfeeding
  6. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)

Key Trial Info

Start Date :

March 22 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

124000 Patients enrolled

Trial Details

Trial ID

NCT05597280

Start Date

March 22 2023

End Date

December 31 2026

Last Update

June 28 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Fondation Damien

Moroni, Comoros

Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy | DecenTrialz