drugset / Trial / NCT02279875
A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the mycobactericidal activity, safety, tolerability, and pharmacokinetics of 6 doses of linezolid: 300 mg once per day, 300 mg twice per day, 600 mg once per day, 600 mg twice per day and 1200 mg once per day administered orally for 14 consecutive days or 1200 mg administered three times per week for two weeks in adult subjects with newly diagnosed drug-sensitive, smear-positive pulmonary tuberculosis.
Timeline
- Start
- 2014-11
- Primary completion
- 2016-11-28
- Completion
- 2017-07
Publications
- Simeon S, Garcia-Cremades M, Savic R, Solans BP. Pharmacokinetic-pharmacodynamic modeling of tuberculosis time to positivity and colony-forming unit to assess the response to dose-ranging linezolid. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0019024. doi: 10.1128/aac.00190-24. Epub 2024 Jul 17.
- Diacon AH, De Jager VR, Dawson R, Narunsky K, Vanker N, Burger DA, Everitt D, Pappas F, Nedelman J, Mendel CM. Fourteen-Day Bactericidal Activity, Safety, and Pharmacokinetics of Linezolid in Adults with Drug-Sensitive Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e02012-19. doi: 10.1128/AAC.02012-19. Print 2020 Mar 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | 275 mg | Oral |
| Comparator | Isoniazid | Small molecule | 75 mg | Oral |
| Subject | Linezolid | Other / unclassified | 300 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | Oral |
| Subject | Linezolid | Other / unclassified | 1200 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 400 mg | Oral |
| Comparator | Rifampin | Small molecule | 150 mg | Oral |