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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

Tracking Information
First Submitted Date March 21, 2012
First Posted Date March 23, 2012
Results First Submitted Date June 9, 2014
Results First Posted Date July 10, 2014
Last Update Posted Date July 10, 2014
Study Start Date November 2008
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2014)
Percentage of Participants With Clinical Success [ Time Frame: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first ]
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.
Original Primary Outcome Measures
 (submitted: March 21, 2012)
  • Clinical outcomes: Cured defined as the complete resolution of signs and symptoms of pneumonia; improvement defined as a partial resolution of signs and symptoms of pneumonia; failure defined as the deterioration of signs and symptoms of pneumonia. [ Time Frame: Up to 28 days after the diagnosis of hospital-acquired pneumonia (HAP) ]
  • Microbiological outcomes will be defined as: superinfections and colonization (positive cultures with a multi-drug resistant organism). [ Time Frame: Up to 28 days after the diagnosis of HAP ]
  • Economic Outcomes: Calculations regarding cost of care for each study arm will be performed by obtaining the following data: length of hospital stay, length of ICU stay, duration of mechanical ventilation, duration of antimicrobial treatment, number of [ Time Frame: Up to 28 days after the diagnosis of HAP ]
  • antibiotic free days. [ Time Frame: Up to 28 days after the diagnosis of HAP ]
Change History Complete list of historical versions of study NCT01561469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 9, 2014)
  • Number of Participants With Microbiological Outcome [ Time Frame: 28 days after diagnosis of VAP ]
    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).
  • Duration of Hospital Stay [ Time Frame: Up to 28 days after diagnosis of VAP ]
    Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.
  • Duration of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 28 days after diagnosis of VAP ]
    Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.
  • Duration of Mechanical Ventilation [ Time Frame: Up to 28 days after diagnosis of VAP ]
    Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.
  • Duration of Antimicrobial Treatment [ Time Frame: Up to 28 days after diagnosis of VAP ]
  • Number of Antibiotic Free Days [ Time Frame: Up to 28 days after diagnosis of VAP ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
Official Title Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin
Brief Summary The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes.
Detailed Description Non-randomized, retrospective, observational study
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This non-interventional study will retrospectively evaluate patients with documented MRSA hospital-acquired including ventilator-associated pneumonia treated with linezolid or vancomycin with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm.
Condition
  • Methicillin-Resistant Staphylococcus Aureus (MRSA)
  • Hospital-Acquired Pneumonia
Intervention
  • Drug: Linezolid
    Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
    Other Name: Zyvox
  • Drug: Vancomycin
    Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.
    Other Name: Vancocin
Study Groups/Cohorts
  • Linezolid observational cohort
    Intervention: Drug: Linezolid
  • Vancomycin observational cohort
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2014)
188
Original Estimated Enrollment
 (submitted: March 21, 2012)
200
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients will be enrolled in the study if they fulfill the following three inclusion criteria:

  1. Protocol criteria for HAP/VAP: Criteria for making a correct diagnosis of HAP will be met if the patient develops a new or progressive pulmonary infiltrate associated with at least two of the following: new or increased respiratory symptomatology (cough, sputum or tracheal secretions, shortness of breath), fever or hypothermia, leukocytosis, left shift, or leukopenia, or deterioration of pulmonary function.
  2. Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP
  3. Treatment of MRSA HAP/VAP with either vancomycin or linezolid with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm

Exclusion Criteria:

Patients not meeting enrollment criteria.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01561469
Other Study ID Numbers A5951168
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators
  • University of Louisville
  • Henry Ford Hospital
  • Summa Health System
  • Sparrow Health System
  • Jackson Health System
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2014