Clinical Trial

Novel Triple-dose Tuberculosis Retreatment Regimen

Study acronym: Tri-Do-Re
Recruiting Phase 3
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.
Summary
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).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-02-05; most recent amendment 2025-04-10.
Status change: Active, Not Recruiting → Recruiting 2025-04-10
Status change: Recruiting → Active, Not Recruiting 2024-02-13
Status change: Not Yet Recruiting → Recruiting 2021-04-22
Trial Details
NCT Number NCT04260477
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: Damien Foundation
Conditions Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs
Enrollment 370 participants
Start Date 2021-03-01
Primary Completion 2025-06 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-04-13