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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2023

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At a glance

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

    • Most Recent Events

    • 01 Sep 2022 Results assessing the efficacy and safety of bedaquiline-pretomanid-linezolid regimens for drug-resistant tuberculosis, published in the New England Journal of Medicine.
    • 26 May 2022 Status changed from active, no longer recruiting to completed.
    • 28 Jan 2022 Planned End Date changed from 2 Dec 2021 to 8 Feb 2022.

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