Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan

May 9, 2011 updated by: Pfizer

Linezolid (PNU-10766/PNU10766SS) in the Treatment of MRSA Infections in Patients Whose Conventional Therapy Has Failed, or Who Are Intolerant to Conventional Therapy; an Open-label, Multi-center Trial

Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 811-0213
        • Pfizer Investigational Site
      • Fukuoka, Japan, 813-0025
        • Pfizer Investigational Site
      • Hiroshima, Japan, 730-8619
        • Pfizer Investigational Site
      • Hiroshima, Japan, 734-8530
        • Pfizer Investigational Site
      • Kyoto, Japan, 615-8256
        • Pfizer Investigational Site
      • Nagasaki, Japan, 852-8501
        • Pfizer Investigational Site
      • Okayama, Japan, 700-8505
        • Pfizer Investigational Site
      • Okayama, Japan, 703-8275
        • Pfizer Investigational Site
    • Chiba
      • Kamogawa, Chiba, Japan, 296-0041
        • Pfizer Investigational Site
    • Fukuoka
      • Onga-gun, Fukuoka, Japan, 807-0051
        • Pfizer Investigational Site
    • Hokkaido
      • Sappopro, Hokkaido, Japan, 060-8648
        • Pfizer Investigational Site
      • Sapporo, Hokkaido, Japan, 006-8555
        • Pfizer Investigational Site
    • Ibaraki
      • Moriya, Ibaraki, Japan, 302-0118
        • Pfizer Investigational Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Pfizer Investigational Site
    • Nagasaki
      • Isahaya, Nagasaki, Japan, 854-8501
        • Pfizer Investigational Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Pfizer Investigational Site
      • Kurashiki, Okayama, Japan, 701-0912
        • Pfizer Investigational Site
    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • Pfizer Investigational Site
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Pfizer Investigational Site
    • Tokyo
      • Kodaira, Tokyo, Japan, 187-0004
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infection due to methicillin-resistant Staphylococcus aureus

Exclusion Criteria:

  • hypersensitivity to linezolid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Resolution of infection at the time of completion of therapy

Secondary Outcome Measures

Outcome Measure
Adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12600067
  • A5951054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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