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

This study has been completed.
Sponsor:
Collaborators:
University of Louisville
Henry Ford Hospital
Summa Health System
Sparrow Health System
Jackson Memorial Hospital
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01561469
First received: March 21, 2012
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Methicillin-Resistant Staphylococcus Aureus (MRSA)
Hospital-Acquired Pneumonia
Drug: Linezolid
Drug: Vancomycin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Clinical Success [ Time Frame: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Microbiological Outcome [ Time Frame: 28 days after diagnosis of VAP ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Antibiotic Free Days [ Time Frame: Up to 28 days after diagnosis of VAP ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: November 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Linezolid observational cohort Drug: Linezolid
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
Other Name: Zyvox
Vancomycin observational cohort Drug: Vancomycin
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.
Other Name: Vancocin

Detailed Description:

Non-randomized, retrospective, observational study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561469

Sponsors and Collaborators
Pfizer
University of Louisville
Henry Ford Hospital
Summa Health System
Sparrow Health System
Jackson Memorial Hospital
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01561469     History of Changes
Other Study ID Numbers: A5951168
Study First Received: March 21, 2012
Results First Received: June 9, 2014
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Linezolid
Vancomycin
Ventilator-Associated Pneumonia
Respiratory Tract Infections

Additional relevant MeSH terms:
Pneumonia
Staphylococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014