At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 240 enrolled
Drug / intervention
PA-824 +4 moredrug
Likely dose
Not stated in 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 2 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide During 8 Weeks of Treatment in Adult Subjects With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis.
In Brief
A Phase 2 clinical trial evaluating PA-824, bedaquiline, and 3 other interventions for Tuberculosis. Completed, enrolled 240 participants across 10 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesSouth Africa, Tanzania, Uganda
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartOct 2014
Primary CompletionFeb 2016
Study CompletionFeb 2018
TodayJul 2026
First PostedJul 18, 2014
Enrollment StartOct 23, 2014
Primary CompletionFeb 8, 2016
Study CompletionFeb 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.0 years ago
Interventions
PA-824drug
oral
bedaquilinedrug
oral
moxifloxacindrug
oral
pyrazinamidedrug
oral
isoniazid, rifampicin, pyrazinamide and ethambutol combination tabletdrug
oral