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

Condition(s) targeted: Infections, Nosocomial

Intervention: linezolid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections 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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Resolution of infection at the time of completion of therapy

Secondary outcome: Adverse events

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- infection due to methicillin-resistant Staphylococcus aureus

Exclusion Criteria:

- hypersensitivity to linezolid

Pfizer Investigational Site, Fukuoka 813-0025, Japan

Pfizer Investigational Site, Fukuoka 811-0213, Japan

Pfizer Investigational Site, Hiroshima 734-8530, Japan

Pfizer Investigational Site, Hiroshima 730-8619, Japan

Pfizer Investigational Site, Kyoto 615-8256, Japan

Pfizer Investigational Site, Nagasaki 852-8501, Japan

Pfizer Investigational Site, Okayama 700-8505, Japan

Pfizer Investigational Site, Okayama 703-8275, Japan

Pfizer Investigational Site, Kamogawa, Chiba 296-0041, Japan

Pfizer Investigational Site, Onga-gun, Fukuoka 807-0051, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 006-8555, Japan

Pfizer Investigational Site, Sappopro, Hokkaido 060-8648, Japan

Pfizer Investigational Site, Moriya, Ibaraki 302-0118, Japan

Pfizer Investigational Site, Yokohama, Kanagawa 236-0051, Japan

Pfizer Investigational Site, Isahaya, Nagasaki 854-8501, Japan

Pfizer Investigational Site, Kurashiki, Okayama 701-0912, Japan

Pfizer Investigational Site, Kurashiki, Okayama, Japan

Pfizer Investigational Site, Suita, Osaka 565-8565, Japan

Pfizer Investigational Site, Iruma-gun, Saitama 350-0495, Japan

Pfizer Investigational Site, Kodaira, Tokyo 187-0004, Japan

Link to Clinicalstudyresults.org posting

Starting date: January 2003
Ending date: February 2006
Last updated: December 13, 2007