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
Price :
$35
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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
- 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