Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
NCT00084266
ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) | |||
Official Title ICMJE | Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus | |||
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. 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Methicillin Resistant Staphylococcus Aureus (MRSA) | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1225 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | March 2010 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Belgium, Brazil, Chile, Colombia, France, Germany, Greece, Hong Kong, Korea, Republic of, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States | |||
Removed Location Countries | Italy, Singapore, Venezuela | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00084266 | |||
Other Study ID Numbers ICMJE | A5951001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |