This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3
experimental regimens with a standard control regimen in participants with newly diagnosed,
drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to
the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1.
In stage 2, the experimental arm 4 containing sutezolid will be added. Participants will be
allocated to control or one of the three experimental regimens in the ratio 1:1:1:1. Towards
the end of stage 2, when experimental arms 1 and 2 will be fully enrolled, participants will
be randomized 1:1 to control and experimental arm 4. The objective is to evaluate the
efficacy, safety, and tolerability of increased dose of rifampicin, an optimized dose of
pyrazinamide, moxifloxacin, and sutezolid, in adult subjects with newly diagnosed,
smear-positive pulmonary tuberculosis.
Phase:
Phase 2
Details
Lead Sponsor:
Michael Hoelscher
Collaborators:
Radboud University Medical Center University College, London University of California, San Francisco