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BPaL(M) Regimen for the Treatment of MDR/RR-TB

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 9 more changesShow less
    • Enrollment target: 50 to 80
    • Start date changed from estimate of Aug 1, 2022 to Dec 13, 2022
    • Interventions: BPaL regimen (Drug) to BPaL(M) regimen (Drug)
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 59 words
    • Site details revised
    • Collaborators: 9 to 12
    • Study title expanded, about 1 word
  2. Start date: Jun 2022 to Aug 1, 2022v3
  3. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid, Linezolid for 26 weeks for the treatment of MDR/RR-TB through the clinical trial.
Trial Details
NCT Number NCT05381194
Lead Sponsor Asan Medical Center
Collaborators: Pusan National University Hospital, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Chonnam National University Hospital, The Catholic University of Korea, Chungbuk National University Hospital, Ulsan University Hospital, Soon Chun Hyang University, Incheon St.Mary's Hospital, DongGuk University, National Medical Center, Seoul
Conditions
(from sponsor)		 Multidrug- and Rifampicin-resistant Tuberculosis
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov