Novel Triple-dose Tuberculosis Retreatment Regimen

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Tropical Medicine, Belgium
• Collaborator: Damien Foundation
• Treatments: Ethambutol; Isoniazid; Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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