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A Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 4 and 6 Months of Treatment in Adult Subjects With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and After 6 Months of Treatment in Adult Subjects With Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis

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Trial Profile

A Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 4 and 6 Months of Treatment in Adult Subjects With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and After 6 Months of Treatment in Adult Subjects With Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

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

Most Recent Events

  • 19 Oct 2020 Status changed to discontinued as per results published in the Antimicrobial Agents and Chemotherapy.
  • 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.
  • 29 Jul 2019 Results of quantitative modeling describing the relationship between pretomanid plasma concentrations and the change from baseline in QTc using data from eight phase 2 and phase 3 studies, published in the Antimicrobial Agents and Chemotherapy

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