June 9, 2004 |
August 13, 2009 |
October 2004 |
To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults [ Time Frame: up to 30 d after completion of treatment ] [ Designated as safety issue: No ] |
To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults |
Complete list of historical versions of study NCT00084266 on ClinicalTrials.gov Archive Site |
To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults [ Time Frame: up to 30 days after end of treatment ] [ Designated as safety issue: Yes ] |
To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults |
|
Nosocomial Pneumonia With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) |
Linezolid in the Treatment of Subjects With Nosocomial Pneumonia Proven to be Due to Methicillin-Resistant Staphylococcus Aureus |
To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to MRSA in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin. |
|
Phase IV |
Interventional |
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Pneumonia, Staphylococcal |
- Drug: linezolid
- Drug: vancomycin
|
- Experimental: Subjects receiving linezolid for the treatment phase of the study
- Active Comparator: Subjects receiving vancomycin for the treatment phase of the study
|
|
|
Recruiting |
1200 |
June 2010 |
June 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 Criteria:
- 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.
|
Both |
18 Years and older |
No |
Contact: Pfizer CT.gov Call Center |
1-800-718-1021 |
|
|
|
United States, Argentina, Belgium, Brazil, Chile, Colombia, France, Germany, Greece, Hong Kong, Korea, Republic of, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Taiwan, Turkey, United Kingdom |
|
|
NCT00084266 |
Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
A5951001 |
Pfizer |
|
Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
Pfizer |
August 2009 |