A Phase 3 Open-label Trial Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Pulmonary Infection of Either Extensively Drug-resistant Tuberculosis (XDR-TB) or Treatment Intolerant / Non-responsive Multi-drug Resistant Tuberculosis (MDR-TB)

Trial Profile

A Phase 3 Open-label Trial Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Pulmonary Infection of Either Extensively Drug-resistant Tuberculosis (XDR-TB) or Treatment Intolerant / Non-responsive Multi-drug Resistant Tuberculosis (MDR-TB)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2017

At a glance

  • Drugs Bedaquiline (Primary) ; Linezolid (Primary) ; Pretomanid (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Therapeutic Use
  • Acronyms Nix-TB
  • Sponsors Global Alliance for TB Drug Development
  • Most Recent Events

    • 16 Feb 2017 Results (n=61) presented at the 24th Conference on Retroviruses and Opportunistic Infections.
    • 25 Mar 2015 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov record.
    • 13 Jan 2015 New trial record
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