Novel Triple-dose Tuberculosis Retreatment Regimen

Recruiting now · Phase 3

Conditions studied: Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs

In brief

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).

Key facts

Study ID

NCT04260477

Run by

Institute of Tropical Medicine, Belgium

People needed

370

Starts

2021-03-01

Expected to finish

2025-09-01

Last updated by the study team

2025-04-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All newly registered patients with smear-positive recurrent pulmonary TB
• Adults as well as children (no age limit)
• Able and willing to provide written informed consent
• Added for stage 2: lives within 5 km of a health facility with a medical doctor

You may not qualify if…

• All patients with TB initially resistant to rifampicin on Xpert MTB/RIF testing
• Patients transferred to a health facility not supported by the Damien Foundation
• Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period
• Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening
• Pregnant or breastfeeding woman
• HIV co-infected patients requiring treatment with a protease inhibitor

Where it is running

• Damien Foundation — Niamey, Niger (enrolling)

Full record on ClinicalTrials.gov

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