At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
TMC207 +1 moredrug
Likely dose
Rifafour e-275 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating TMC207 and Rifafour e-275 mg for Pulmonary Tuberculosis. Completed, enrolled 68 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Tuberculosis
CountriesSouth Africa
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2010
Primary CompletionAug 2010
Study CompletionSep 2010
First PostedOct 2010
TodayJul 2026
First PostedOct 6, 2010
Enrollment StartApr 1, 2010
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.7 years ago
Interventions
TMC207drug
Rifafour e-275 mgdrug