A Study of Quabodepistat-containing Regimen for the Treatment of Drug-resistant Pulmonary Tuberculosis

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

532

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

May 28, 2027

Study Completion Date

September 29, 2028

Conditions
Pulmonary Tuberculosis
Interventions
DRUG

BPaQM

Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin 400 mg once daily for 17 weeks

DRUG

BPaLM

Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks + Moxifloxacin 400 mg once daily for 26 weeks

DRUG

BPaQ

Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Quabodepistat 30 mg once daily for 26 weeks

DRUG

BPaL

Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks

Trial Locations (34)

1100

Lung Center Of The Philippines, Quezon City

1632

The Aurum Institute - Tembisa Hospital Clinical Research Centre, Johannesburg

1772

Tropical Disease Foundation, Makati City

2000

Jose B. Lingad Memorial Regional Hospital, San Fernando City

2092

Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital, Johannesburg

2131

Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital,, Johannesburg

2574

Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit, Klerksdorp

4013

Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban

4118

Silang Specialist Medical Center, Silang

5241

Synergy Biomed Research Institute, East London

6003

Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital, Port Elizabeth

7405

Brooklyn Chest Hospital, Belville

7700

UCT - Lung Infection and Immunity Unit, Cape Town

UCT Lung Institute, Cape Town

15012

Socios en Salud Sucursal Peru, La Molina

15313

Hospital Sergio E. Bernales, Lima

15837

Centro de Investigación del Hospital de Emergencias de Villa el Salvador, Villa El Salvador

21431

The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon

49241

Pusan National University Hospital, Busan

101100

Capital Medical University - Beijing Chest Hospital, Beijing

200040

Huashan Hospital Fudan University, Shanghai

200433

Shanghai Pulmonary Hospital - Pneumology, Shanghai

210003

The Second Hospital of Nanjing, Nanjing

430032

Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital), Wuhan

518112

The Third People's Hospital of Shenzhen, Shenzhen

610041

Public Health Clinical Center of Chengdu, Chengdu

0101

National Center for Tuberculosis and Lung Disease, Tbilisi

204-8522

Japan Anti-Tuberculosis Association Fukujuji Hospital, Kiyose

MD-2025

IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology, Chisinau

0152

Setshaba Research Center, Pretoria

0250

Madibeng Centre for Research, Brits

0299

The Aurum Institute - Rustenburg, Rustenburg

03080

Seoul National University Hospital - Pulmonology, Seoul

05505

Asan Medical Center - Pulmonology, Seoul

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY