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A Randomised, Controlled, Open-Label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis

Trial Profile

A Randomised, Controlled, Open-Label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 07 May 2024

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At a glance

  • Drugs Bedaquiline (Primary) ; Linezolid (Primary) ; Pretomanid (Primary) ; Clofazimine; Moxifloxacin
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms TB-PRACTECAL

Most Recent Events

  • 30 Apr 2024 Status changed from discontinued to recruiting.
  • 22 Dec 2022 Primary endpoint has been met. (Stage 2: Percentage of patients with an unfavourable outcome (failure, death, recurrence, loss to follow-up), as per Results published in the New England Journal of Medicine
  • 22 Dec 2022 Results published in the New England Journal of Medicine

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