Novel Triple-dose Tuberculosis Retreatment Regimen

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorInstitute of Tropical Medicine, Belgium

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

370 Participants
are divided into 2 treatment groups

Sponsors and collaborators