drugset / Trial / NCT01215851
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of change of log CFU in sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-05
- Completion
- 2011-08
Outcome
Met primary endpoint
paper The mean 14-day EBA of PA-824-moxifloxacin-pyrazinamide (n=13; 0·233 [SD 0·128]) was significantly higher than that of bedaquiline PMID 22828481 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 400 mg | Oral |
| Comparator | Ethambutol | Small molecule | 550 mg | — |
| Comparator | Ethambutol | Small molecule | 825 mg | — |
| Comparator | Ethambutol | Small molecule | 1100 mg | — |
| Comparator | Ethambutol | Small molecule | 1375 mg | — |
| Comparator | Isoniazid | Small molecule | 150 mg | — |
| Comparator | Isoniazid | Small molecule | 225 mg | — |
| Comparator | Isoniazid | Small molecule | 300 mg | — |
| Comparator | Isoniazid | Small molecule | 375 mg | — |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | Pretomanid | Small molecule | 200 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 800 mg | — |
| Comparator | Pyrazinamide | Small molecule | 1000 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 1200 mg | — |
| Comparator | Pyrazinamide | Small molecule | 1500 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 1600 mg | — |
| Comparator | Pyrazinamide | Small molecule | 2000 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 2000 mg | — |
| Comparator | Rifampicin | Small molecule | 300 mg | — |
| Comparator | Rifampicin | Small molecule | 450 mg | — |
| Comparator | Rifampicin | Small molecule | 600 mg | — |
| Comparator | Rifampicin | Small molecule | 750 mg | — |