Status:
COMPLETED
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Lead Sponsor:
Pfizer
Conditions:
Methicillin Resistant Staphylococcus Aureus (MRSA)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Sub...
Eligibility Criteria
Inclusion
- Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
- Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
- Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.
Exclusion
- Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
- Subjects with severe neutropenia (\<500 cells/mm3)
- Subjects with hypersensitivity to oxazolidinones or vancomycin.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
1225 Patients enrolled
Trial Details
Trial ID
NCT00084266
Start Date
October 1 2004
End Date
March 1 2010
Last Update
February 1 2012
Active Locations (177)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35249
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
4
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801