clinical trial · NCT05971602
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
Gates Medical Research Institute·phase2·terminated·n = 93
Pulmonary TuberculosisDelamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS)Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS)Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS)Isoniazid and Rifampicin (HR)
brief summary
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).
started
Jul 26, 2023
primary completion
Feb 6, 2025
completion
Feb 6, 2025
last updated
Feb 25, 2025
official title
A Phase 2b/c, Multi-Arm, 2-Stage, Duration Randomized Trial of the Efficacy and Safety of Two to Four Months Treatment With Regimens Containing Bedaquiline, OPC-167832, and Sutezolid, Plus Either Pretomanid or Delamanid, in Adults With Pulmonary Tuberculosis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol