Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05597280 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

Study acronym: BE-PEOPLE P3
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Dec 31, 2026 to Mar 15, 2027v4
  2. Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 5 to 6
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2023 to Mar 22, 2023
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05597280
Lead Sponsor Institute of Tropical Medicine, Belgium
Conditions
(from sponsor)		 Leprosy
Related terms Leprosy
Enrollment 124,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov