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

Primary Purpose

Infections, Nosocomial

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
linezolid
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Nosocomial

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: infection due to methicillin-resistant Staphylococcus aureus Exclusion Criteria: hypersensitivity to linezolid

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Resolution of infection at the time of completion of therapy

Secondary Outcome Measures

Adverse events

Full Information

First Posted
September 6, 2005
Last Updated
May 9, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00150332
Brief Title
Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Nosocomial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
linezolid
Primary Outcome Measure Information:
Title
Resolution of infection at the time of completion of therapy
Secondary Outcome Measure Information:
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infection due to methicillin-resistant Staphylococcus aureus Exclusion Criteria: hypersensitivity to linezolid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kamogawa
State/Province
Chiba
ZIP/Postal Code
296-0041
Country
Japan
Facility Name
Pfizer Investigational Site
City
Onga-gun
State/Province
Fukuoka
ZIP/Postal Code
807-0051
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sappopro
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Pfizer Investigational Site
City
Moriya
State/Province
Ibaraki
ZIP/Postal Code
302-0118
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Pfizer Investigational Site
City
Isahaya
State/Province
Nagasaki
ZIP/Postal Code
854-8501
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0912
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Pfizer Investigational Site
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-0004
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
811-0213
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
813-0025
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama
ZIP/Postal Code
700-8505
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama
ZIP/Postal Code
703-8275
Country
Japan

12. IPD Sharing Statement

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

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