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

Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA 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.

Study Overview

• Status: Completed
• Conditions: Hospital-Acquired Pneumonia; Methicillin-Resistant Staphylococcus Aureus (MRSA)
• Intervention / Treatment: Drug: Linezolid; Drug: Vancomycin

Detailed Description

Non-randomized, retrospective, observational study

• Study Type: Observational
• Enrollment (Actual): 188

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Linezolid observational cohort	Drug: Linezolid; Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.; Other Names: 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 Names: Vancocin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: University of Louisville; Summa Health System; Sparrow Health System; Jackson Health System; Henry Ford Hospital

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (ESTIMATE): March 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2014
• Last Update Submitted That Met QC Criteria: June 9, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Vancomycin; Respiratory Tract Infections; Ventilator-Associated Pneumonia; Linezolid
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Staphylococcal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Vancomycin; Linezolid
• Other Study ID Numbers: A5951168