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A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis

Study acronym: QUANTUM-TB
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 33 to 35v4
  2. Study sites: 34 to 33v3
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 15, 2025 to Oct 16, 2025 · Eligibility criteria expanded, about 26 words · Site details revised at 34 of 34 sites · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Oct 15, 2025 to Oct 16, 2025
    • Eligibility criteria expanded, about 26 words
    • Site details revised at 34 of 34 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.
Trial Details
NCT Number NCT07209761
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Pulmonary Tuberculosis
Enrollment 532 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov