At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 181 enrolled
Drug / intervention
Pretomanid +3 moredrug
Likely dose
Pretomanid 200mgfrom 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 Partially-blinded, Randomized Trial Assessing the Safety and Efficacy of Various Doses and Treatment Durations of Linezolid Plus Bedaquiline and Pretomanid in Participants With Pulmonary Infection of Either Extensively Drug-resistant Tuberculosis (XDR-TB), Pre-XDR-TB or Treatment Intolerant or Non-responsive Multi-drug Resistant Tuberculosis (MDR-TB)
In Brief
A Phase 3 clinical trial evaluating Pretomanid, Linezolid, and 2 other interventions for Tuberculosis, Pulmonary and 6 related conditions. Completed, enrolled 181 participants across 11 sites in 4 countries.
Detailed Summary
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pre-XDR-TB, XDR-TB
CountriesGeorgia, Moldova, Russia, South Africa
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartNov 2017
Primary CompletionFeb 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedMar 22, 2017
Enrollment StartNov 21, 2017
Primary CompletionFeb 15, 2021
Study CompletionFeb 8, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.3 years ago
Interventions
Pretomaniddrug
200mg tablets
Linezoliddrug
Scored 600mg tablets
Bedaquilinedrug
100mg tablets
Placebo Linezoliddrug
Scored 600 mg tablets