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TERMINATED
NCT05971602
PHASE2

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Sponsor: Gates Medical Research Institute

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

93

Start Date

2023-07-26

Completion Date

2025-02-06

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

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.

Locations (13)

Tropical Disease Foundation

Makati, Philippines

Lung Center of the Philippines

Quezon City, Philippines

Silang Specialist Medical Center

Silang, Philippines

Bio-Medical Research Institute; Faculty of Medicine and Health Sciences, Stellenbosch University; Tygerberg Medical Campus

Cape Town, South Africa

TASK - Central (Brooklyn)

Cape Town, South Africa

UCT (Cape Town); General Medicine & Global Health (GMGH); Hatter Heart Research Institute

Cape Town, South Africa

UCT South African Tuberculosis Vaccine Initiative (SATVI)

Cape Town, South Africa

University of Cape Town (UCT) Lung Institute

Cape Town, South Africa

CHRU - Durban

Durban, South Africa

Synergy Biomed Research Institute

East London, South Africa

Clinical HIV Research Unit (CHRU) - Johannesburg

Johannesburg, South Africa

The Aurum Institute (Tembisa CRS)

Johannesburg, South Africa

Perinatal HIV Research Unit (PHRU)

Klerksdorp, South Africa