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Novel Triple-dose Tuberculosis Retreatment Regimen

Study acronym: Tri-Do-Re
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 13, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Active, Not Recruiting to Recruiting
    • Primary endpoints revised (3)
    • Secondary endpoints: 11 to 17
    • Site details revised
    v9
  2. Primary completion date: Nov 2024 to Jun 2025v8 Show 6 more changesShow less
    • Primary endpoints: 1 to 3
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 2024 to Sep 2025
    • Eligibility criteria expanded, about 16 words
    • Study description expanded, about 34 words
    • Site details revised
  3. 2 versions Re-verified since Oct 29, 2021, no change to tracked fieldsv6-v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  5. Start date: Jan 1, 2021 to Mar 1, 2021v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 2020 to Jan 1, 2021v3
  2. Primary endpoint revised
    • Secondary endpoints revised (11)
    • Study description expanded, about 2 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).
Trial Details
NCT Number NCT04260477
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: Damien Foundation
Conditions
(from sponsor)		 Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs
Related terms Tuberculosis, Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary
Enrollment 370 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov