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

This study has been completed.

First Received on September 6, 2005. Last Updated on May 9, 2011 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150332

Purpose

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

Condition	Intervention	Phase
Infections, Nosocomial	Drug: linezolid	Phase III

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:

Drug Information available for: Linezolid

U.S. FDA Resources

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 February 09, 2012