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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2024

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At a glance

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

    • Most Recent Events

    • 22 Feb 2023 Results (n=93) investigating the relationship between patient characteristics and efficacy endpoints collected in the Nix-TB trial, presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023
    • 12 Feb 2023 Results (n=93) of an analysis assessing relationship between pharmacokinetic characteristics of drugs, patient characteristics and efficacy endpoints published in the Clinical Infectious Diseases
    • 19 Nov 2020 Status changed from active, no longer recruiting to completed.

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