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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS)	D- 300 milligram (mg) once daily (QD) for treatment duration; B- 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S- 1200 mg QD for treatment duration
DRUG	Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS)	P- 200 mg QD for treatment duration; B- 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S- 1200 mg QD for treatment duration
DRUG	Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)	Fixed dose combination (FDC) of 75 mg of isoniazid, 150 mg of rifampicin, 400 mg of pyrazinamide, and 275 mg of ethambutol (HRZE) (Standard of Care \[SOC\]). All the doses administered will be weight-based.
DRUG	Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS)	X - Pretomanid 200 mg QD for treatment duration OR Delamanid 300 mg QD for treatment duration; B - 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S-1200 mg QD for treatment duration
DRUG	Isoniazid and Rifampicin (HR)	Fixed dose combination (FDC) of 75 mg of isoniazid and 150 mg of rifampicin (HR) (Standard of Care \[SOC\]). All the doses administered will be weight-based.

Timeline

• Start date: 2023-07-26
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2023-08-02
• Last updated: 2025-02-25

Locations

13 sites across 2 countries: Philippines, South Africa