Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) (ZEPHYR)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00084266 |
Recruitment Status :
Completed
First Posted : June 11, 2004
Results First Posted : May 9, 2011
Last Update Posted : February 1, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Methicillin Resistant Staphylococcus Aureus (MRSA) | Drug: linezolid (Zyvox) Drug: vancomycin | Phase 4 |
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 |

Arm | Intervention/treatment |
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Experimental: 1
Subjects receiving linezolid for the treatment phase of the study
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 |
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.

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

United States, Alabama | |
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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 | |
United States, Hawaii | |
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Honolulu, Hawaii, United States, 96817 | |
United States, Illinois | |
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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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Springfield, Illinois, United States, 62701 | |
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Springfield, Illinois, United States, 62702 | |
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Springfield, Illinois, United States, 62703 | |
United States, Indiana | |
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New Albany, Indiana, United States, 47151 | |
United States, Kentucky | |
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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 | |
United States, Maryland | |
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Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
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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 | |
United States, Michigan | |
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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 | |
United States, Missouri | |
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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 | |
United States, Nebraska | |
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Omaha, Nebraska, United States, 68131 | |
United States, Nevada | |
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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 | |
United States, New Jersey | |
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Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
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Albany, New York, United States, 12208 | |
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Bronx, New York, United States, 10457 | |
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Brooklyn, New York, United States, 11215 | |
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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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New York, New York, United States, 10029 | |
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Rochester, New York, United States, 14642-8410 | |
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Rochester, New York, United States, 14642 | |
United States, North Carolina | |
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Greensboro, North Carolina, United States, 27401 | |
United States, North Dakota | |
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Fargo, North Dakota, United States, 58112 | |
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Fargo, North Dakota, United States, 58122 | |
United States, Ohio | |
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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, 43210 | |
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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 | |
United States, Oregon | |
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Portland, Oregon, United States, 97213 | |
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Portland, Oregon, United States, 97220 | |
United States, Pennsylvania | |
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Abington, Pennsylvania, United States, 19001 | |
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Allentown, Pennsylvania, United States, 18103 | |
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Bethlehem, Pennsylvania, United States, 18017 | |
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Philadelphia, Pennsylvania, United States, 19102 | |
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Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Rhode Island | |
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Providence, Rhode Island, United States, 02903 | |
United States, South Carolina | |
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Charleston, South Carolina, United States, 29425 | |
United States, South Dakota | |
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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 | |
United States, Tennessee | |
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Nashville, Tennessee, United States, 37232-7110 | |
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Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
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Houston, Texas, United States, 77030-1608 | |
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Irving, Texas, United States, 75061 | |
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San Antonio, Texas, United States, 78229 | |
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San Antonio, Texas, United States, 78284 | |
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San Marcos, Texas, United States, 78666 | |
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Sequin, Texas, United States, 78155 | |
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Temple, Texas, United States, 76508 | |
United States, Utah | |
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Murray, Utah, United States, 84157 | |
United States, Virginia | |
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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 | |
Belgium | |
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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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Staphylococcal pneumonia Methicillin-resistant staphylococcal pneumonia healthcare-associated pneumonia |
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 |