Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan
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
2 other identifiers
interventional
24
1 country
20
Brief Summary
Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2003
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedMay 10, 2011
May 1, 2011
September 6, 2005
May 9, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Resolution of infection at the time of completion of therapy
Secondary Outcomes (1)
Adverse events
Interventions
Eligibility Criteria
You may qualify if:
- infection due to methicillin-resistant Staphylococcus aureus
You may not qualify if:
- hypersensitivity to linezolid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (20)
Pfizer Investigational Site
Kamogawa, Chiba, 296-0041, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, 811-0213, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, 813-0025, Japan
Pfizer Investigational Site
Onga-gun, Fukuoka, 807-0051, Japan
Pfizer Investigational Site
Hiroshima, Hiroshima, 730-8619, Japan
Pfizer Investigational Site
Hiroshima, Hiroshima, 734-8530, Japan
Pfizer Investigational Site
Sappopro, Hokkaido, 060-8648, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, 006-8555, Japan
Pfizer Investigational Site
Moriya, Ibaraki, 302-0118, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, 236-0051, Japan
Pfizer Investigational Site
Kyoto, Kyoto, 615-8256, Japan
Pfizer Investigational Site
Isahaya, Nagasaki, 854-8501, Japan
Pfizer Investigational Site
Nagasaki, Nagasaki, 852-8501, Japan
Pfizer Investigational Site
Kurashiki, Okayama-ken, 701-0912, Japan
Pfizer Investigational Site
Kurashiki, Okayama-ken, Japan
Pfizer Investigational Site
Okayama, Okayama-ken, 700-8505, Japan
Pfizer Investigational Site
Okayama, Okayama-ken, 703-8275, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
January 1, 2003
Study Completion
January 1, 2006
Last Updated
May 10, 2011
Record last verified: 2011-05