drugset / Trial / NCT02256696
Assessing PA-824 for Tuberculosis (the APT Trial)
RandomizedParallel-groupOpen-labelTreatment
Summary
Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA Office of Orphan Products Development (OOPD)
Timeline
- Start
- 2015-04-29
- Primary completion
- 2022-05-01
- Completion
- 2022-05-01
Outcome
Mixed primary results
registry analysis (superiority test); Arm 1 vs Arm 3; p = 0.10; Hazard Ratio (HR) 1.41 (95% CI 0.93 to 2.12); Regression, Cox NCT02256696 ↗
registry analysis (superiority test); Arm 2 vs Arm 3; p = 0.003; Hazard Ratio (HR) 1.89 (95% CI 1.24 to 2.87); Regression, Cox NCT02256696 ↗
Publications
- Dooley KE, Hendricks B, Gupte N, Barnes G, Narunsky K, Whitelaw C, Smit T, Ignatius EH, Friedman A, Dorman SE, Dawson R; Assessing Pretomanid for Tuberculosis (APT) Study Team. Assessing Pretomanid for Tuberculosis (APT), a Randomized Phase 2 Trial of Pretomanid-Containing Regimens for Drug-Sensitive Tuberculosis: 12-Week Results. Am J Respir Crit Care Med. 2023 Apr 1;207(7):929-935. doi: 10.1164/rccm.202208-1475OC.
- Ignatius EH, Abdelwahab MT, Hendricks B, Gupte N, Narunsky K, Wiesner L, Barnes G, Dawson R, Dooley KE, Denti P. Pretomanid Pharmacokinetics in the Presence of Rifamycins: Interim Results from a Randomized Trial among Patients with Tuberculosis. Antimicrob Agents Chemother. 2021 Jan 20;65(2):e01196-20. doi: 10.1128/AAC.01196-20. Print 2021 Jan 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pretomanid | Small molecule | 200 mg | — |
| Subject | Rifabutin | Small molecule | 300 mg | — |
| Subject | Rifampicin | Small molecule | 600 mg | — |
| Comparator | Ethambutol | Small molecule | 15 mg/kg | — |
| Background | Isoniazid | Small molecule | 300 mg | — |
| Background | Pyrazinamide | Small molecule | 25 mg/kg | — |