Overview

A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)

Status:
Completed
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Global Alliance for TB Drug Development
Treatments:
Ethambutol
Isoniazid
Linezolid
Pyrazinamide
Rifampin