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A Phase 2 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide During 8 Weeks of Treatment in Adult Subjects With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis.

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Trial Profile

A Phase 2 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide During 8 Weeks of Treatment in Adult Subjects With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Bedaquiline (Primary) ; Moxifloxacin (Primary) ; Pretomanid (Primary) ; Pyrazinamide (Primary) ; Rifampicin/isoniazid/pyrazinamide/ethambutol
  • Indications Pulmonary tuberculosis
  • Focus Therapeutic Use
  • Sponsors Global Alliance for TB Drug Development

    • Most Recent Events

    • 19 Oct 2020 Results of pooled data of four studies and four pretomanid-containing regimens NC-002, NC-005, STAND, and Nix-TB, retrospectively evaluating the recommended daily dose of pretomanid, 200 mg administered with food, by means of exposure-response modeling applied to outcomes of both efficacy and safety, published in the Antimicrobial Agents and Chemotherapy.
    • 19 Aug 2019 New trial record

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