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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150332
First received: September 6, 2005
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Infections, Nosocomial
Drug: linezolid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Resolution of infection at the time of completion of therapy

Secondary Outcome Measures:
  • Adverse events

Enrollment: 24
Study Start Date: January 2003
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infection due to methicillin-resistant Staphylococcus aureus

Exclusion Criteria:

  • hypersensitivity to linezolid
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150332

Locations
Japan
Pfizer Investigational Site
Kamogawa, Chiba, Japan, 296-0041
Pfizer Investigational Site
Onga-gun, Fukuoka, Japan, 807-0051
Pfizer Investigational Site
Sappopro, Hokkaido, Japan, 060-8648
Pfizer Investigational Site
Sapporo, Hokkaido, Japan, 006-8555
Pfizer Investigational Site
Moriya, Ibaraki, Japan, 302-0118
Pfizer Investigational Site
Yokohama, Kanagawa, Japan, 236-0051
Pfizer Investigational Site
Isahaya, Nagasaki, Japan, 854-8501
Pfizer Investigational Site
Kurashiki, Okayama, Japan, 701-0912
Pfizer Investigational Site
Kurashiki, Okayama, Japan
Pfizer Investigational Site
Suita, Osaka, Japan, 565-8565
Pfizer Investigational Site
Iruma-gun, Saitama, Japan, 350-0495
Pfizer Investigational Site
Kodaira, Tokyo, Japan, 187-0004
Pfizer Investigational Site
Fukuoka, Japan, 813-0025
Pfizer Investigational Site
Fukuoka, Japan, 811-0213
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00150332     History of Changes
Other Study ID Numbers: M12600067, A5951054
Study First Received: September 6, 2005
Last Updated: May 9, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Cross Infection
Staphylococcal Infections
Infection
Gram-Positive Bacterial Infections
Bacterial Infections
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014