Ultra-Short Regimen for Elderly DS-TB

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

July 25, 2025

Primary Completion Date

January 31, 2030

Study Completion Date

July 31, 2030

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

All Listed Sponsors
collaborator

Beijing Chest Hospital, Capital Medical University

OTHER

collaborator

Fudan University

OTHER

collaborator

West China Hospital

OTHER

collaborator

Huazhong University of Science and Technology

OTHER

collaborator

Tsinghua University

OTHER

lead

Shenzhen Third People's Hospital

OTHER