About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 6EH³R³Z
- 6EHRZ
Treatment groups
Sponsors and collaborators
Institute of Tropical Medicine, Belgium
Lead sponsor
Damien Foundation
Collaborator