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An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)

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Trial Profile

An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Sep 2024

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At a glance

  • Drugs Bedaquiline (Primary) ; Moxifloxacin (Primary) ; Pretomanid (Primary) ; Pyrazinamide (Primary) ; Ethambutol; Isoniazid; Rifampicin
  • Indications Tuberculosis
  • Focus Therapeutic Use
  • Acronyms SimpliciTB
  • Sponsors Global Alliance for TB Drug Development

Most Recent Events

  • 01 Sep 2024 Results published in The Lancet Infectious Diseases
  • 22 Feb 2023 Primary endpoint (Time to culture conversion to negative status over 8 weeks) has been met, as per results presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023.
  • 22 Feb 2023 Results assessing hepatic safety of pretomanid regimens with or without pyrazinamide in tuberculosis patients, presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023.

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