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

Study Overview
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Brief Summary
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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
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Non-randomized, retrospective, observational study

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

Conditions
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Methicillin-Resistant Staphylococcus Aureus (MRSA), Hospital-Acquired Pneumonia

Intervention / Treatment
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* Drug: Linezolid
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Linezolid observational cohort<br> | Drug: Linezolid<br>* Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.<br>* Other names: Zyvox;|
| Vancomycin observational cohort<br> | Drug: Vancomycin<br>* Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.<br>* Other names: Vancocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Clinical Success | 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. | 14 days after diagnosis with VAP or hospital discharge, whichever occurred first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Microbiological Outcome | 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). | 28 days after diagnosis of VAP | 
| Duration of Hospital Stay | Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital. | Up to 28 days after diagnosis of VAP | 
| Duration of Intensive Care Unit (ICU) Stay | Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU. | Up to 28 days after diagnosis of VAP | 
| Duration of Mechanical Ventilation | Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated. | Up to 28 days after diagnosis of VAP | 
| Duration of Antimicrobial Treatment |  | Up to 28 days after diagnosis of VAP | 
| Number of Antibiotic Free Days |  | Up to 28 days after diagnosis of VAP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Linezolid, Vancomycin, Ventilator-Associated Pneumonia, Respiratory Tract Infections