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A Phase II Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 8 Weeks of Treatment in Adult Patients With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis

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A Phase II Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 8 Weeks of Treatment in Adult Patients With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs 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

    • 17 Mar 2021 Results (n= 2744) of pooled analysis from 3 studies (NCT00864383, NCT01498419 & NCT00694629) evaluating short term time to positivity (TTP) biomarker in liquid culture as a predictor of individual TSCC and trial level HR, presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 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
    • 02 May 2015 Results published in the Lancet.

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