search
Back to results

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

Primary Purpose

Methicillin Resistant Staphylococcus Aureus (MRSA)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
linezolid (Zyvox)
vancomycin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methicillin Resistant Staphylococcus Aureus (MRSA) focused on measuring Staphylococcal pneumonia, Methicillin-resistant staphylococcal pneumonia, healthcare-associated pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Subjects receiving linezolid for the treatment phase of the study

Subjects receiving vancomycin for the treatment phase of the study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 9, 2004
Last Updated
January 30, 2012
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00084266
Brief Title
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Acronym
ZEPHYR
Official Title
Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin Resistant Staphylococcus Aureus (MRSA)
Keywords
Staphylococcal pneumonia, Methicillin-resistant staphylococcal pneumonia, healthcare-associated pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subjects receiving linezolid for the treatment phase of the study
Arm Title
2
Arm Type
Active Comparator
Arm Description
Subjects receiving vancomycin for the treatment phase of the study
Intervention Type
Drug
Intervention Name(s)
linezolid (Zyvox)
Other Intervention Name(s)
Zyvox, linezolid
Intervention Description
Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
vancomycin
Intervention Description
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 Measure Information:
Title
Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population
Description
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.
Time Frame
EOS (7-30 days after last dose)
Secondary Outcome Measure Information:
Title
Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population
Description
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.
Time Frame
EOS (7-30 days after last dose)
Title
Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
Description
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.
Time Frame
EOT (within 72 hours of last dose)
Title
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
Description
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.
Time Frame
EOT (within 72 hours of last dose)
Title
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Description
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.
Time Frame
EOS (7-30 days after last dose)
Title
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Description
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.
Time Frame
EOS (7-30 days after last dose)
Title
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Description
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.
Time Frame
EOT (within 72 hours of last dose)
Title
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Description
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.
Time Frame
EOT (within 72 hours of last dose)
Title
Number of Participants With Clinical Signs and Symptoms at EOS for PP Population
Description
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.
Time Frame
EOS (7-30 days after last dose)
Title
Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population
Description
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.
Time Frame
EOS (7-30 days after last dose)
Title
Number of Participants With Clinical Signs and Symptoms at EOT for PP Population
Description
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.
Time Frame
EOT (within 72 hours of last dose)
Title
Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population
Description
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.
Time Frame
EOT (within 72 hours of last dose)
Title
Survival Status Estimated by Kaplan-Meier Analysis for PP Population
Description
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.
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.
Title
Survival Status Estimated by Kaplan-Meier Analysis for mITT Population
Description
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.
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.
Title
Survival Status Estimated by Kaplan-Meier Analysis for ITT Population
Description
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.
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.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
27600290
Citation
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.
Results Reference
derived
PubMed Identifier
26196695
Citation
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.
Results Reference
derived
PubMed Identifier
24279701
Citation
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.
Results Reference
derived
PubMed Identifier
24011955
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951001&StudyName=Nosocomial%20Pneumonia%20With%20Suspected%20Or%20Proven%20Methicillin-Resistant%20Staphylococcus%20Aureus%20%28MRSA%29
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs