At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
PA-824 +4 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 PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
In Brief
A Phase 2 clinical trial evaluating PA-824 and Rifafour e-275 mg for Pulmonary Tuberculosis. Completed, enrolled 69 participants.
Detailed Summary
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Tuberculosis
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionJan 2010
Study CompletionMay 2010
TodayJul 2026
First PostedJul 22, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.9 years ago
Interventions
PA-824drug
50mg
PA-824drug
100mg
PA-824drug
150 mg
Rifafour e-275 mgdrug
275 mg
PA-824drug
200 mg