drugset / Trial / NCT02342886
Shortening Treatment by Advancing Novel Drugs
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard HRZE treatment. This study will also assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin, PA-824, and pyrazinamide treatments in DS-TB subjects.
Timeline
- Start
- 2015-02
- Primary completion
- 2018-01
- Completion
- 2018-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | — | Oral |
| Comparator | Isoniazid | Small molecule | — | Oral |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | Pretomanid | Small molecule | 100 mg | Oral |
| Subject | Pretomanid | Small molecule | 200 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 1500 mg | Oral |
| Comparator | Rifampin | Small molecule | — | Oral |