Trial intelligence / Profile preview

Linezolid Ophthalmologic Function Study

NCT00359632Phase 3

Key facts

Status
Terminated
Start
Nov 2008
Primary completion
Dec 2013
Countries
3
Sponsor
Pfizer
Modality
Small Molecules
Conditions
bacterial infection
01

Overview

Phase 3, open-label trial of linezolid in bacterial infection (2 arms), sponsored by Pfizer. Primary endpoint: Percentage of Participants With an Adverse Event. Started Nov 2008; status: terminated.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • Linezolid

    Patients receiving Linezolid for >= 6 weeks

  • Matched Control

    Patients receiving other antibiotics for >= 6 weeks (Baseline only)

03

Who it enrols

Adult patients receiving linezolid for 6+ weeks or matched controls on other antibiotics. Excludes patients with pre-existing optic/peripheral nerve damage or severe liver disease.

04

Endpoints

Primary

  • Percentage of Participants With an Adverse Event

Secondary

  • Percentage of Participants by Clinical Outcome of Infection at End of Study

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