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Completed

NCT Number: NCT01561469

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

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.

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Key information

Conditions

Methicillin-Resistant Staphylococcus Aureus (MRSA) Cross Infection Disease Attributes Healthcare-Associated Pneumonia Hospital-acquired Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Non-randomized, retrospective, observational study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP
  • 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.

Treatment and study plan

Linezolid

Drug

Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.

Other names: Zyvox

Vancomycin

Drug

Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.

Other names: Vancocin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. Duration of Antimicrobial Treatment

    Time frame: Up to 28 days after diagnosis of VAP

  6. Number of Antibiotic Free Days

    Time frame: Up to 28 days after diagnosis of VAP

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Henry Ford Hospital
  • Jackson Health System
  • Sparrow Health System
  • Summa Health System
  • University of Louisville

Registry information

Official study title

Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 23, 2012
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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