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Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin

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ClinicalTrials.gov Identifier: NCT01561469
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Collaborators:
University of Louisville
Henry Ford Hospital
Summa Health System
Sparrow Health System
Jackson Health System
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Methicillin-Resistant Staphylococcus Aureus (MRSA)
Hospital-Acquired Pneumonia
Interventions Drug: Linezolid
Drug: Vancomycin
Enrollment 188
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP. Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Period Title: Overall Study
Started 101 87
Completed 101 87
Not Completed 0 0
Arm/Group Title Linezolid Vancomycin Total
Hide Arm/Group Description Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP. Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP. Total of all reporting groups
Overall Number of Baseline Participants 101 87 188
Hide Baseline Analysis Population Description
Analysis population included all participants who met the eligibility criteria for this study.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 101 participants 87 participants 188 participants
59
(48 to 68)
56
(40 to 66)
57
(45.75 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 87 participants 188 participants
Female
38
  37.6%
38
  43.7%
76
  40.4%
Male
63
  62.4%
49
  56.3%
112
  59.6%
1.Primary Outcome
Title Percentage of Participants With Clinical Success
Hide Description Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.
Time Frame 14 days after diagnosis with VAP or hospital discharge, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who met the eligibility criteria for this study.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Number of Participants Analyzed 101 87
Measure Type: Number
Unit of Measure: percentage of participants
85 69
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Microbiological Outcome
Hide Description Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).
Time Frame 28 days after diagnosis of VAP
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who met the eligibility criteria for this study.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Number of Participants Analyzed 101 87
Measure Type: Number
Unit of Measure: participants
Superinfections 42 37
Colonization 34 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments Analysis for superinfections category reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments Analysis for colonization category reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.759
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Duration of Hospital Stay
Hide Description Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.
Time Frame Up to 28 days after diagnosis of VAP
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who met the eligibility criteria for this study.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Number of Participants Analyzed 101 87
Median (Inter-Quartile Range)
Unit of Measure: days
18
(10 to 28)
16
(11 to 25.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.773
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Duration of Intensive Care Unit (ICU) Stay
Hide Description Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.
Time Frame Up to 28 days after diagnosis of VAP
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who met the eligibility criteria for this study.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Number of Participants Analyzed 101 87
Median (Inter-Quartile Range)
Unit of Measure: days
11
(8 to 22)
13
(8 to 19.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.
Time Frame Up to 28 days after diagnosis of VAP
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who met the eligibility criteria for this study.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Number of Participants Analyzed 101 87
Median (Inter-Quartile Range)
Unit of Measure: days
11
(11 to 24)
13
(9.5 to 24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Duration of Antimicrobial Treatment
Hide Description [Not Specified]
Time Frame Up to 28 days after diagnosis of VAP
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who met the eligibility criteria for this study.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Number of Participants Analyzed 101 87
Mean (Standard Deviation)
Unit of Measure: days
11  (4) 11  (5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Number of Antibiotic Free Days
Hide Description [Not Specified]
Time Frame Up to 28 days after diagnosis of VAP
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Due to retrospective nature of the study, adverse events data was not collected.
 
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP. Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
All-Cause Mortality
Linezolid Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Linezolid Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Linezolid Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Prioritization of endpoints as primary or secondary was not specified in protocol and was based on study team's inputs.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01561469     History of Changes
Other Study ID Numbers: A5951168
First Submitted: March 21, 2012
First Posted: March 23, 2012
Results First Submitted: June 9, 2014
Results First Posted: July 10, 2014
Last Update Posted: July 10, 2014