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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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Methicillin Resistant Staphylococcus Aureus (MRSA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Subjects receiving linezolid for the treatment phase of the study

Group Type EXPERIMENTAL

linezolid (Zyvox)

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

vancomycin

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Zyvox, linezolid

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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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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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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United States Argentina Belgium Brazil Chile Colombia France Germany Greece Hong Kong Malaysia Mexico Poland Portugal Puerto Rico Russia South Africa South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

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.

Reference Type DERIVED
PMID: 27600290 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26196695 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24279701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24011955 (View on PubMed)

Other Identifiers

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A5951001

Identifier Type: -

Identifier Source: org_study_id

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