A PAN-USR TB Multi-Center Trial

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

610

Participants

Timeline

Start Date

April 15, 2025

Primary Completion Date

January 31, 2029

Study Completion Date

December 31, 2029

Conditions
Pulmonary Tuberculosis
Interventions
DRUG

Bedaquiline (B)

The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week.

DRUG

Sitafloxacin (S)

200mg once daily

DRUG

Linezolid (L)

600mg once daily

DRUG

Pyrazinamide (Z)

20-30 mg/kg/day; 1000 mg for patients weighing \<50 kg, 1500 mg for patients weighing ≥50 kg but \<75 kg, and 2000 mg for patients weighing ≥75 kg.

DRUG

Isoniazid (H)

4-6 mg/kg once daily, 300 mg once daily

DRUG

Rifampicin (R)

8-12 mg/kg once daily, 450 mg for patients weighing \<50 kg, 600 mg for patients weighing ≥50 kg but \<75 kg, and 750 mg for patients weighing ≥75 kg.

DRUG

Ethambutol (E)

15-25 mg/kg once daily, 750 mg once daily

DRUG

Moxifloxacin (M)

400mg once daily

DRUG

Pretomanid (Pa)

200mg once daily

All Listed Sponsors
collaborator

First Affiliated Hospital of Zhejiang University

OTHER

collaborator

Beijing Chest Hospital of Capital Medical University

UNKNOWN

collaborator

Shenyang Tenth People's Hospital

OTHER

collaborator

The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region

UNKNOWN

collaborator

The Fourth Hospital of Inner Mongolia Autonomous Region

UNKNOWN

collaborator

Guizhou Aerospace Hospital

UNKNOWN

lead

Shenzhen Third People's Hospital

OTHER