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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)

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)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Aug 2018

At a glance

  • Drugs Bedaquiline (Primary) ; Moxifloxacin (Primary) ; Pretomanid (Primary) ; Pyrazinamide (Primary) ; Ethambutol; Isoniazid; Rifampicin
  • Indications Tuberculosis
  • Focus Therapeutic Use
  • Most Recent Events

    • 28 Aug 2018 According to TB Alliancemedia release, study will be conducted across at least 26 centers in 10 countries in Africa, Asia, Europe and Latin America.
    • 28 Aug 2018 According to TB Alliancemedia release, The first patients have been enrolled at the National Center for Tuberculosis and Lung Disease in Tbilisi, Georgia
    • 07 Aug 2018 Planned End Date changed from 1 Mar 2022 to 31 Jan 2022.
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