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Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

Study acronym: DRAMATIC
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Secondary endpoints: details revised at 1 of 1 entryv20 Show 4 more changesShow less
    • Study description expanded, about 10 words
    • Study sites revised (2)
    • Collaborators: 10 to 9
    • Eligibility criteria expanded, about 2 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 220 to confirmed 271
    • Primary and study completion dates: May 31, 2027 to May 2027
    • Site details revised at 2 of 2 sites
    v19
  3. Primary and study completion dates: May 2027 to May 31, 2027v18
  4. Primary and study completion dates: May 31, 2027 to May 2027v17
  5. Primary and study completion dates: May 2027 to May 31, 2027v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary and study completion dates: Jul 2025 to May 2027
    • Eligibility criteria expanded, about 29 words
    • Site details revised at 1 of 2 sites
    v15
  2. Re-verified, no change to tracked fieldsv14
  3. Start date changed from estimate of Jun 2022 to Jun 7, 2022v13
  4. Start date: May 2022 to Jun 2022v12
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2022 to May 2022
    • Site details revised at 2 of 2 sites
    v11
  6. Start date: Mar 2022 to Apr 2022v10
  7. Start date: Feb 2022 to Mar 2022v9
  8. Start date: Jan 2022 to Feb 2022v8
  9. Start date: Dec 2021 to Jan 2022v7
  10. Start date: Nov 2021 to Dec 2021v6
  11. Start date: Sep 2021 to Nov 2021v5
  12. Start date: Jul 2021 to Sep 2021v4
  13. Phase: Phase 3 to Phase 2v3 Show 14 more changesShow less
    • Trial status: Withdrawn to Not Yet Recruiting
    • Primary and study completion dates: Jan 2024 to Jul 2025
    • Start date: Jan 2020 to Jul 2021
    • Primary endpoints revised (2)
    • Enrollment target: 0 to 220
    • Study sites: 0 to 2
    • Interventions: Bedaquiline (Drug), Clofazimine (Drug), Delamanid (Drug), Levofloxacin (Drug), Linezolid (Drug), WHO approved MDR-TB treatment regimens… to Bedaquiline (Drug), Clofazimine (Drug), Delamanid (Drug), Levofloxacin (Drug), Linezolid (Drug)
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: 7 to 1
    • Study description shortened, about 189 words
    • Collaborators: 4 to 10
    • Publications: 6 to 1
    • Study arms: 3 to 4
    • Study title shortened, about 3 words
  14. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: The study could not be conducted since funding was not obtained
    • Enrollment target: estimated 465 to confirmed 0
    v2
  1. 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.
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs. It occurs in 3.6% of newly diagnosed TB patients in the world and 17% of patients who have been previously treated. In 2017, approximately 600,000 people were estimated to have acquired MDR-TB. However, only 25% of persons with MDR-TB were diagnosed and started on treatment, reflecting inadequate diagnostic capacity and lack of TB treatment capacity. In this multicenter, randomized, partially blinded, four-arm, phase 2 study, the investigators will examine the efficacy and safety of an all-oral regimen of bedaquiline, delamanid, levofloxacin, linezolid, and clofazimine given for 16, 24, 32 or 40 weeks
Trial Details
NCT Number NCT03828201
Lead Sponsor Boston University
Collaborators: Novartis Pharmaceuticals, Pfizer, Otsuka Pharmaceutical Co., Ltd., University of California, San Francisco, National Institute of Allergy and Infectious Diseases (NIAID), University of Colorado, Denver, Harvard Medical School (HMS and HSDM), National Lung Hospital, Vietnam, TB-HIV Innovations & Clinical Research Foundation Corp, Philippines
Conditions
(from sponsor)		 Tuberculosis, Multidrug-Resistant
Related terms Tuberculosis, Multidrug-Resistant
Enrollment 271 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov