Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
NCT ID: NCT00084266
Last Updated: 2012-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1225 participants
INTERVENTIONAL
2004-10-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Subjects receiving linezolid for the treatment phase of the study
linezolid (Zyvox)
Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
2
Subjects receiving vancomycin for the treatment phase of the study
vancomycin
Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Interventions
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linezolid (Zyvox)
Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
vancomycin
Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with severe neutropenia (\<500 cells/mm3)
* Subjects with hypersensitivity to oxazolidinones or vancomycin.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Orange, California, United States
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Redlands, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Brandon, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jackson, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Augusta, Georgia, United States
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Decatur, Georgia, United States
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Decatur, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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North Chicago, Illinois, United States
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Oak Park, Illinois, United States
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Springfield, Illinois, United States
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Springfield, Illinois, United States
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Springfield, Illinois, United States
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New Albany, Indiana, United States
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Hazard, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Saint Loius, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Reno, Nevada, United States
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Hackensack, New Jersey, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Greensboro, North Carolina, United States
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Fargo, North Dakota, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Sylvania, Ohio, United States
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Toledo, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Abington, Pennsylvania, United States
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Allentown, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Sequin, Texas, United States
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Temple, Texas, United States
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Murray, Utah, United States
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Richmond, Virginia, United States
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Winchester, Virginia, United States
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Buenos Aires, Buenos Aires, Argentina
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Bruges, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Salvador, Estado de Bahia, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Santiago, RM, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, , Chile
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Barranquilla, Atlántico, Colombia
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Bogotá, Bogota. DC, Colombia
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Bogota, Cundinamarca, Colombia
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Ibagué, Tolima Department, Colombia
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Paris, Cedex 18, France
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Marseille, France, France
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Paris, , France
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Saint-Etienne, , France
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Göttingen, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Kifissia, Athens, Greece
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Crete, Greece, Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey/Col. Mitras Centro, Nuevo Léon, Mexico
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Ciudad Madero, Tamaulipas, Mexico
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Bytom, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Almada, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Senhora da Hora, , Portugal
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
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Moscow, Russia, Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Auckland Park, , South Africa
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Bloefontein, , South Africa
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Soweto, , South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badalona, Barcelona, Spain
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Barcelona, Barcelona, Spain
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Barcelona, Barcelona, Spain
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Madrid, Madrid, Spain
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Banqiao District, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Plymouth, Devon, United Kingdom
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Edinburgh, , United Kingdom
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, ,
Countries
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References
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Equils O, da Costa C, Wible M, Lipsky BA. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin. BMC Infect Dis. 2016 Sep 6;16(1):476. doi: 10.1186/s12879-016-1779-5.
Shorr AF, Puzniak LA, Biswas P, Niederman MS. Predictors of Clinical Success in the Treatment of Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) Nosocomial Pneumonia (NP). PLoS One. 2015 Jul 21;10(7):e0131932. doi: 10.1371/journal.pone.0131932. eCollection 2015.
Quartin AA, Scerpella EG, Puttagunta S, Kett DH. A comparison of microbiology and demographics among patients with healthcare-associated, hospital-acquired, and ventilator-associated pneumonia: a retrospective analysis of 1184 patients from a large, international study. BMC Infect Dis. 2013 Nov 27;13:561. doi: 10.1186/1471-2334-13-561.
Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.
Other Identifiers
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A5951001
Identifier Type: -
Identifier Source: org_study_id
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