drugset / Trial / NCT01215110
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
RandomizedParallel-groupDouble-blindTreatment
Summary
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of log10 colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.
Timeline
- Start
- 2010-04
- Primary completion
- 2010-08
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 100 mg | Oral |
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Bedaquiline | Small molecule | 300 mg | Oral |
| Subject | Bedaquiline | Small molecule | 400 mg | Oral |
| Comparator | Rifafour e | Unknown | 275 mg | — |