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

Infections, Nosocomial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150332
• Other study ID #: M12600067
• Secondary ID: A5951054
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: May 9, 2011
• Start date: January 2003
• Est. completion date: January 2006

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• infection due to methicillin-resistant Staphylococcus aureus

Exclusion Criteria:

• hypersensitivity to linezolid

Study Design

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

Related Conditions & MeSH terms

• Cross Infection
• Infection
• Infections, Nosocomial

Intervention

Drug:
• linezolid

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Hiroshima
Japan	Pfizer Investigational Site	Hiroshima
Japan	Pfizer Investigational Site	Iruma-gun	Saitama
Japan	Pfizer Investigational Site	Isahaya	Nagasaki
Japan	Pfizer Investigational Site	Kamogawa	Chiba
Japan	Pfizer Investigational Site	Kodaira	Tokyo
Japan	Pfizer Investigational Site	Kurashiki	Okayama
Japan	Pfizer Investigational Site	Kurashiki	Okayama
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Moriya	Ibaraki
Japan	Pfizer Investigational Site	Nagasaki
Japan	Pfizer Investigational Site	Okayama
Japan	Pfizer Investigational Site	Okayama
Japan	Pfizer Investigational Site	Onga-gun	Fukuoka
Japan	Pfizer Investigational Site	Sappopro	Hokkaido
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Suita	Osaka
Japan	Pfizer Investigational Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of infection at the time of completion of therapy
Secondary	Adverse events