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A Novel Therapy With a 1-Month Ultrashort Regimen to Halt Progression From Latent Infection to Active Tuberculosis Among Close Contacts (The TB-YOUTH Study)

Study acronym: TB-YOUTH
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 14, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint revised
    • Study sites: 47 to 66
    • Secondary endpoints: 4 to 6
    • Study title expanded, about 9 words
    v8
  2. Minor Enrollment target: 2978 to 3520
    • Secondary endpoints revised (4)
    v7
  3. Minor Eligibility criteria expanded, about 39 wordsv6
  4. Minor Enrollment target: 3520 to 2978v5 Show 4 more changesShow less
    • Study sites: 6 to 47
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 9 words
    • Eligibility criteria shortened, about 5 words
  5. Minor Enrollment target: 3316 to 3520
    • Study sites: 1 to 6
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Start date changed from estimate of Sep 13, 2023 to Sep 1, 2023v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 1, 2023 to Sep 13, 2023
    • Site details revised
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.
Trial Details
NCT Number NCT06022146
Lead Sponsor Huashan Hospital
Conditions
(from sponsor)
Tuberculosis, Latent Tuberculosis
Related terms Latent Tuberculosis, Tuberculosis
Enrollment 3,520 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov