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

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ClinicalTrials.gov Identifier: NCT00084266
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : May 9, 2011
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Methicillin Resistant Staphylococcus Aureus (MRSA) Drug: linezolid (Zyvox) Drug: vancomycin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
Study Start Date : October 2004
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA Pneumonia

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 Name: 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.




Primary Outcome Measures :
  1. Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population [ Time Frame: EOS (7-30 days after last dose) ]
    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.


Secondary Outcome Measures :
  1. Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population [ Time Frame: EOS (7-30 days after last dose) ]
    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.

  2. Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population [ Time Frame: EOT (within 72 hours of last dose) ]
    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.

  3. Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population [ Time Frame: EOT (within 72 hours of last dose) ]
    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.

  4. Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population [ Time Frame: EOS (7-30 days after last dose) ]
    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.

  5. Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population [ Time Frame: EOS (7-30 days after last dose) ]
    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.

  6. Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population [ Time Frame: EOT (within 72 hours of last dose) ]
    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.

  7. Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population [ Time Frame: EOT (within 72 hours of last dose) ]
    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.

  8. Number of Participants With Clinical Signs and Symptoms at EOS for PP Population [ Time Frame: EOS (7-30 days after last dose) ]
    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.

  9. Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population [ Time Frame: EOS (7-30 days after last dose) ]
    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.

  10. Number of Participants With Clinical Signs and Symptoms at EOT for PP Population [ Time Frame: EOT (within 72 hours of last dose) ]
    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.

  11. Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population [ Time Frame: EOT (within 72 hours of last dose) ]
    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.

  12. Survival Status Estimated by Kaplan-Meier Analysis for PP Population [ Time Frame: 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. ]
    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.

  13. Survival Status Estimated by Kaplan-Meier Analysis for mITT Population [ Time Frame: 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. ]
    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.

  14. Survival Status Estimated by Kaplan-Meier Analysis for ITT Population [ Time Frame: 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. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084266


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00084266     History of Changes
Other Study ID Numbers: A5951001
First Posted: June 11, 2004    Key Record Dates
Results First Posted: May 9, 2011
Last Update Posted: February 1, 2012
Last Verified: January 2012
Keywords provided by Pfizer:
Staphylococcal pneumonia
Methicillin-resistant staphylococcal pneumonia
healthcare-associated pneumonia
Additional relevant MeSH terms:
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Staphylococcal Infections
Healthcare-Associated Pneumonia
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Vancomycin
Linezolid
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action