Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) (ZEPHYR)

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 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.

Study Overview

• Status: Completed
• Conditions: Methicillin Resistant Staphylococcus Aureus (MRSA)
• Intervention / Treatment: Drug: linezolid (Zyvox); Drug: vancomycin

• Study Type: Interventional
• Enrollment (Actual): 1225
• Phase: Phase 4

Contacts and Locations

Study Locations

• • • Pfizer Investigational Site
• Argentina
  • Buenos Aires, Argentina, 1181
    • Pfizer Investigational Site
• Belgium
  • Brugge, Belgium, 8000
    • Pfizer Investigational Site
  • Brussels, Belgium, 1070
    • Pfizer Investigational Site
  • Gent, Belgium, 9000
    • Pfizer Investigational Site
  • Liege 1, Belgium, B-4000
    • Pfizer Investigational Site
• Brazil
  • BA
    • Salvador, BA, Brazil, 40420-000
      • Pfizer Investigational Site
  • SP
    • Sao Jose do Rio Preto, SP, Brazil, 15090-000
      • Pfizer Investigational Site
    • São Paulo, SP, Brazil, 05651-901
      • Pfizer Investigational Site
• Chile
  • Santiago, Chile
    • Pfizer Investigational Site
  • RM
    • Santiago, RM, Chile
      • Pfizer Investigational Site
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Pfizer Investigational Site
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Pfizer Investigational Site
  • Bogota. DC
    • Bogota, Bogota. DC, Colombia
      • Pfizer Investigational Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Pfizer Investigational Site
  • Tolima
    • Ibague, Tolima, Colombia
      • Pfizer Investigational Site
• France
  • Marseille Cedex 20, France, 13915
    • Pfizer Investigational Site
  • Paris, France, 75013
    • Pfizer Investigational Site
  • Saint Etienne Cedex 02, France, 42055
    • Pfizer Investigational Site
  • Cedex 18
    • Paris, Cedex 18, France, 75877
      • Pfizer Investigational Site
• Germany
  • Goettingen, Germany, 37075
    • Pfizer Investigational Site
  • Leipzig, Germany, 04289
    • Pfizer Investigational Site
  • Leipzig, Germany, 04129
    • Pfizer Investigational Site
• Greece
  • Athens, Greece, 10676
    • Pfizer Investigational Site
  • Crete, Greece, 71110
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 57010
    • Pfizer Investigational Site
  • Athens
    • Kifisia, Athens, Greece, 14561
      • Pfizer Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Pfizer Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 150-713
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 134-701
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 136-705
    • Pfizer Investigational Site
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Pfizer Investigational Site
  • Kuala Lumpur, Malaysia, 59100
    • Pfizer Investigational Site
• Mexico
  • DF
    • Mexico, DF, Mexico, 14000
      • Pfizer Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Pfizer Investigational Site
  • Nuevo Léon
    • Monterrey/Col. Mitras Centro, Nuevo Léon, Mexico, 64460
      • Pfizer Investigational Site
  • Tamaulipas
    • Ciudad Madero, Tamaulipas, Mexico, 89440
      • Pfizer Investigational Site
• Poland
  • Bytom, Poland, 41-902
    • Pfizer Investigational Site
  • Katowice, Poland, 40-752
    • Pfizer Investigational Site
  • Krakow, Poland, 31 - 066
    • Pfizer Investigational Site
  • Krakow, Poland, 31-066
    • Pfizer Investigational Site
• Portugal
  • Almada, Portugal, 2800
    • Pfizer Investigational Site
  • Coimbra, Portugal, 3041
    • Pfizer Investigational Site
  • Lisboa, Portugal, 1449-005
    • Pfizer Investigational Site
  • Senhora da Hora, Portugal, 4464-513
    • Pfizer Investigational Site
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Pfizer Investigational Site
  • San Juan, Puerto Rico, 00921-3201
    • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 113093
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 111539
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 115446
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 123448
    • Pfizer Investigational Site
  • Russia
    • Moscow, Russia, Russian Federation, 117049
      • Pfizer Investigational Site
• South Africa
  • Auckland Park, South Africa, 2006
    • Pfizer Investigational Site
  • Bloefontein, South Africa, 9301
    • Pfizer Investigational Site
  • Soweto, South Africa, 2013
    • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • Pfizer Investigational Site
  • Barcelona, Spain, 08003
    • Pfizer Investigational Site
  • Madrid, Spain, 28040
    • Pfizer Investigational Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Pfizer Investigational Site
• Taiwan
  • Kaohsiung, Taiwan, 813
    • Pfizer Investigational Site
  • Pan-Chiao, Taiwan, 220
    • Pfizer Investigational Site
  • Taichung, Taiwan, 404
    • Pfizer Investigational Site
  • Taipei, Taiwan, 100
    • Pfizer Investigational Site
• Turkey
  • Ankara, Turkey, 06100
    • Pfizer Investigational Site
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Pfizer Investigational Site
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Pfizer Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35249
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35294
      • Pfizer Investigational Site
    • Huntsville, Alabama, United States, 35801
      • Pfizer Investigational Site
    • Montgomery, Alabama, United States, 36106
      • Pfizer Investigational Site
    • Montgomery, Alabama, United States, 36111
      • Pfizer Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Pfizer Investigational Site
  • California
    • Los Angeles, California, United States, 90033
      • Pfizer Investigational Site
    • Orange, California, United States, 92868
      • Pfizer Investigational Site
    • Redlands, California, United States, 92373
      • Pfizer Investigational Site
    • Sacramento, California, United States, 95817
      • Pfizer Investigational Site
    • San Diego, California, United States, 92120
      • Pfizer Investigational Site
    • San Diego, California, United States, 92123
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94110
      • Pfizer Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80205
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80204
      • Pfizer Investigational Site
  • Delaware
    • Newark, Delaware, United States, 19718
      • Pfizer Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Pfizer Investigational Site
    • Washington, District of Columbia, United States, 20017
      • Pfizer Investigational Site
  • Florida
    • Brandon, Florida, United States, 33511
      • Pfizer Investigational Site
    • Fort Lauderdale, Florida, United States, 33316
      • Pfizer Investigational Site
    • Gainesville, Florida, United States, 32610
      • Pfizer Investigational Site
    • Jackson, Florida, United States, 32209
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32209
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33136
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32806
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32801
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33607
      • Pfizer Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Pfizer Investigational Site
    • Augusta, Georgia, United States, 30912
      • Pfizer Investigational Site
    • Decatur, Georgia, United States, 30033
      • Pfizer Investigational Site
    • Decatur, Georgia, United States, 30030
      • Pfizer Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Pfizer Investigational Site
    • North Chicago, Illinois, United States, 60064
      • Pfizer Investigational Site
    • Oak Park, Illinois, United States, 60302-2566
      • Pfizer Investigational Site
    • Springfield, Illinois, United States, 62701
      • Pfizer Investigational Site
    • Springfield, Illinois, United States, 62702
      • Pfizer Investigational Site
    • Springfield, Illinois, United States, 62703
      • Pfizer Investigational Site
  • Indiana
    • New Albany, Indiana, United States, 47151
      • Pfizer Investigational Site
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Pfizer Investigational Site
    • Lexington, Kentucky, United States, 40536
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40202
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40206
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Pfizer Investigational Site
    • Boston, Massachusetts, United States, 02114
      • Pfizer Investigational Site
    • Boston, Massachusetts, United States, 02111
      • Pfizer Investigational Site
    • Boston, Massachusetts, United States, 02115
      • Pfizer Investigational Site
    • Springfield, Massachusetts, United States, 01199
      • Pfizer Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0331
      • Pfizer Investigational Site
    • Detroit, Michigan, United States, 48202
      • Pfizer Investigational Site
    • Detroit, Michigan, United States, 48201
      • Pfizer Investigational Site
    • Detroit, Michigan, United States, 48210
      • Pfizer Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110-1010
      • Pfizer Investigational Site
    • St. Loius, Missouri, United States, 63110
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63110
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Pfizer Investigational Site
    • Reno, Nevada, United States, 89502
      • Pfizer Investigational Site
    • Reno, Nevada, United States, 89503
      • Pfizer Investigational Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Pfizer Investigational Site
  • New York
    • Albany, New York, United States, 12208
      • Pfizer Investigational Site
    • Bronx, New York, United States, 10457
      • Pfizer Investigational Site
    • Brooklyn, New York, United States, 11215
      • Pfizer Investigational Site
    • Buffalo, New York, United States, 14215
      • Pfizer Investigational Site
    • New York, New York, United States, 10029
      • Pfizer Investigational Site
    • New York, New York, United States, 10011
      • Pfizer Investigational Site
    • New York, New York, United States, 10021-9800
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14642
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14642-8410
      • Pfizer Investigational Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Pfizer Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58112
      • Pfizer Investigational Site
    • Fargo, North Dakota, United States, 58122
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45267-0558
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43210
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43214
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43215
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43222
      • Pfizer Investigational Site
    • Sylvania, Ohio, United States, 43560
      • Pfizer Investigational Site
    • Toledo, Ohio, United States, 43608
      • Pfizer Investigational Site
    • Toledo, Ohio, United States, 43614
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97213
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97220
      • Pfizer Investigational Site
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Pfizer Investigational Site
    • Allentown, Pennsylvania, United States, 18103
      • Pfizer Investigational Site
    • Bethlehem, Pennsylvania, United States, 18017
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19102
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Pfizer Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Pfizer Investigational Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Pfizer Investigational Site
    • Sioux Falls, South Dakota, United States, 57104
      • Pfizer Investigational Site
    • Sioux Falls, South Dakota, United States, 57117-5045
      • Pfizer Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Pfizer Investigational Site
    • Nashville, Tennessee, United States, 37232-7110
      • Pfizer Investigational Site
  • Texas
    • Houston, Texas, United States, 77030-1608
      • Pfizer Investigational Site
    • Irving, Texas, United States, 75061
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78284
      • Pfizer Investigational Site
    • San Marcos, Texas, United States, 78666
      • Pfizer Investigational Site
    • Sequin, Texas, United States, 78155
      • Pfizer Investigational Site
    • Temple, Texas, United States, 76508
      • Pfizer Investigational Site
  • Utah
    • Murray, Utah, United States, 84157
      • Pfizer Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Pfizer Investigational Site
    • Winchester, Virginia, United States, 22601
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Subjects receiving linezolid for the treatment phase of the study	Drug: 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.; Other Names: Zyvox, linezolid
Active Comparator: 2; Subjects receiving vancomycin for the treatment phase of the study	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population	Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.	EOS (7-30 days after last dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population	Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.	EOS (7-30 days after last dose)
Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population	Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.	EOT (within 72 hours of last dose)
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population	Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.	EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population	Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.	EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population	Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.	EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population	Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.	EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population	Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.	EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for PP Population	Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.	EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population	Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.	EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for PP Population	Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.	EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population	Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.	EOT (within 72 hours of last dose)
Survival Status Estimated by Kaplan-Meier Analysis for PP Population	For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.	From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Survival Status Estimated by Kaplan-Meier Analysis for mITT Population	For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.	From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Survival Status Estimated by Kaplan-Meier Analysis for ITT Population	For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.	From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: June 9, 2004
• First Submitted That Met QC Criteria: June 10, 2004
• First Posted (Estimate): June 11, 2004

Study Record Updates

• Last Update Posted (Estimate): February 1, 2012
• Last Update Submitted That Met QC Criteria: January 30, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: healthcare-associated pneumonia; Staphylococcal pneumonia; Methicillin-resistant staphylococcal pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Staphylococcal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Vancomycin; Linezolid
• Other Study ID Numbers: A5951001