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

PHASE2TerminatedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

July 26, 2023

Primary Completion Date

February 6, 2025

Study Completion Date

February 6, 2025

Conditions
Pulmonary Tuberculosis
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.

Trial Locations (13)

Unknown

Tropical Disease Foundation, Makati

Lung Center of the Philippines, Quezon City

Silang Specialist Medical Center, Silang

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

TASK - Central (Brooklyn), Cape Town

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

UCT South African Tuberculosis Vaccine Initiative (SATVI), Cape Town

University of Cape Town (UCT) Lung Institute, Cape Town

CHRU - Durban, Durban

Synergy Biomed Research Institute, East London

Clinical HIV Research Unit (CHRU) - Johannesburg, Johannesburg

The Aurum Institute (Tembisa CRS), Johannesburg

Perinatal HIV Research Unit (PHRU), Klerksdorp

All Listed Sponsors
collaborator

Global Alliance for TB Drug Development

OTHER

collaborator

Janssen Pharmaceuticals

INDUSTRY

collaborator

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

lead

Gates Medical Research Institute

OTHER