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Short-course Regimens for the Treatment of Pulmonary Tuberculosis

Study acronym: CRUSH-TB
StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 4 of 10 entries
    • Study description expanded, about 27 words
    • Site details revised at 1 of 8 sites
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 12 to 8
    v4
  3. Primary completion date: Oct 30, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Oct 30, 2024 to Oct 30, 2025
    • Start date changed from estimate of Mar 1, 2023 to Nov 21, 2023
    • Study sites: 15 to 12
    • Study completion date: Apr 30, 2026 to Dec 31, 2026
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week. The first 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) (BMZRB) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) (2 BMZRb/2 BMRb, Arm 1) The Second 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus delamanid (D or DLM); (BMZD) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD, Arm 2) The standard 26-week treatment control regimen which is two months of isoniazid, rifampin, ethambutol, and pyrazinamide (2HRZE) followed by four months of isoniazid and rifampin (4HR); (2HRZE/4HR, Arm 3) Target enrollment is 288 male and female participants (96/arm). participants. Participants will be followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first.
Trial Details
NCT Number NCT05766267
Lead Sponsor Centers for Disease Control and Prevention
Collaborators: Tuberculosis Trials Consortium
Conditions
(from sponsor)		 Tuberculosis, Pulmonary, Tuberculosis Infection
Related terms Latent Tuberculosis, Tuberculosis, Pulmonary
Enrollment 288 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov