Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06905522 | A PAN-USR TB Multi-Center Trial | PHASE3 | RECRUITING | 610 | — | — | Jun 18, 2025 | Dec 1, 2029 | Dec 1, 2025 | 3 | China |
Percentage of patients with unfavorable outcomes (failure, treatment interruption, death, loss to follow-up, re-treatment, recurrence) at 12 months (52 weeks) after randomization
Percentage of patients who have treatment interruption due to any reason or died within 2 months (9 weeks) after randomization
| Arm | Type | Description |
|---|---|---|
| Drug-susceptible TB (A1) | EXPERIMENTAL | 2 months (9 weeks) BLSZ regimen: The treatment involves the use of bedaquiline (B), linezolid (L), sitafloxacin (S), and pyrazinamide (Z) throughout the entire process. At the end of 2 months (9 weeks) of treatment, if the sputum smear is still positive or if clinical symptoms have not improved, the treatment duration can be extended to 13 weeks. After the extended treatment period (3 months or 13 weeks), if the sputum smear remains positive or if clinical symptoms have not been relieved, the patient should be switched to the standard treatment regimen, and the subject should be withdrawn from the study. |
| Drug-resistant TB (A2) | EXPERIMENTAL | 2 months (9 weeks) BLSZ regimen: The treatment involves the use of bedaquiline (B), linezolid (L), sitafloxacin (S), and pyrazinamide (Z) throughout the entire process. At the end of 2 months (9 weeks) of treatment, if the sputum smear is still positive or if clinical symptoms have not improved, the treatment duration can be extended to 13 weeks. After the extended treatment period (3 months or 13 weeks), if the sputum smear remains positive or if clinical symptoms have not been relieved, the patient should be switched to the standard treatment regimen, and the subject should be withdrawn from the study. |
| Drug-susceptible TB (B) | ACTIVE_COMPARATOR | 2HRZE/4HR (26 weeks): Four drugs-isoniazid (H), rifampicin (R), pyrazinamide (Z), and ethambutol (E)-are used during the first 2 months of the intensive phase. This is followed by 4 months of consolidation treatment, during which only isoniazid and rifampicin are used. |
| Drug-resistant TB (C) | ACTIVE_COMPARATOR | 6 months (26 weeks) of BPaLM: The treatment involves the use of bedaquiline (B), pretomanid (Pa), linezolid (L), and moxifloxacin (M) throughout the entire course. If the sputum culture remains positive at 4 months, or if clinical symptoms are not relieved by 6 months, or if chest CT results show worsening at 6 months, the treatment may be extended to 9 months. If the patient chooses to withdraw from the study at 6 months, they are allowed to do so. |
| Name | Type | Description |
|---|---|---|
| Bedaquiline (B) | DRUG | The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week. |
| Sitafloxacin (S) | DRUG | 200mg once daily |
| Linezolid (L) | DRUG | 600mg once daily |
| Pyrazinamide (Z) | DRUG | 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. |
| Isoniazid (H) | DRUG | 4-6 mg/kg once daily, 300 mg once daily |
| Rifampicin (R) | DRUG | 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. |
| Ethambutol (E) | DRUG | 15-25 mg/kg once daily, 750 mg once daily |
| Moxifloxacin (M) | DRUG | 400mg once daily |
| Pretomanid (Pa) | DRUG | 200mg once daily |
Inclusion criteria: 1. Age range from 18 to 65 years old, regardless of gender; 2. Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis; 3. Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium...