PanACEA Sutezolid Dose-finding and Combination Evaluation
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This study is an open-label, randomized, controlled, multi-center Phase IIB dose-finding
trial to evaluate the safety, tolerability, pharmacokinetics and
exposure-response-relationship of different doses of sutezolid (STZ) in combination with
bedaquiline, delamanid and moxifloxacin in adults with newly diagnosed, uncomplicated, smear
positive and drug sensitive pulmonary tuberculosis. Participants will be randomized to one of
five arms containing bedaquiline, delamanid and moxifloxacin with different doses of STZ
(0mg, 600mg once daily (OD), 1200mg OD, 600 mg twice daily (BD), 800 mg BD). Study treatment
duration will be three months, followed by a follow-up period of 2 weeks.
The primary objective is to identify the optimal dose of sutezolid to be used in subsequent
studies that provides the best efficacy at acceptable safety of the drug by describing the
safety, tolerability and exposure toxicity relationship of sutezolid (and its main
metabolite) given over three months, in combination with standard-dose bedaquiline, delamanid
and moxifloxacin, compared to standard-dose bedaquiline, delamanid and moxifloxacin alone.
Phase:
Phase 2
Details
Lead Sponsor:
Michael Hoelscher
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP) German Federal Ministry of Education and Research Radboud University Sequella, Inc. University of California, San Francisco
Treatments:
Bedaquiline Diarylquinolines Midazolam Moxifloxacin Norgestimate, ethinyl estradiol drug combination Oxazolidinones