Trials / Completed
CompletedNCT01215110
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
A Phase II Dose Ranging Trial to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of TMC207 in Adult Patients With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Global Alliance for TB Drug Development · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TMC207 | |
| DRUG | Rifafour e-275 mg |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2010-08-01
- Completion
- 2010-09-01
- First posted
- 2010-10-06
- Last updated
- 2017-04-26
- Results posted
- 2017-04-26
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT01215110. Inclusion in this directory is not an endorsement.