At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 109 enrolled
Drug / intervention
Bedaquiline +2 moredrug
Likely dose
Bedaquiline 100mgfrom 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 3 Open-label Trial Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Participants With Pulmonary Infection of Either XDR-TB or Treatment Intolerant / Non-responsive MDR-TB.
In Brief
A Phase 3 clinical trial evaluating Bedaquiline, PA-824, and 1 other intervention for Pulmonary Tuberculosis. Completed, enrolled 109 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture positive at month 4) in participants with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Tuberculosis
CountriesSouth Africa
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMar 2015
Primary CompletionJan 2019
Study CompletionAug 2020
TodayJul 2026
First PostedJan 7, 2015
Enrollment StartMar 1, 2015
Primary CompletionJan 14, 2019
Study CompletionAug 3, 2020
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.5 years ago
Interventions
Bedaquilinedrug
100mg tablets
PA-824drug
200mg tablets
Linezoliddrug
Scored 600mg tablets