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Clinical Trials/NCT01561469
NCT01561469CompletedNot Applicable

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

Pfizer0 sites188 target enrollmentStarted: November 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Pfizer
Enrollment
188
Primary Endpoint
Percentage of Participants With Clinical Success
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Linezolid observational cohort

Intervention: Linezolid (Drug)

Vancomycin observational cohort

Intervention: Vancomycin (Drug)

Outcomes

Primary Outcomes

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

  • Duration of Intensive Care Unit (ICU) Stay(Up to 28 days after diagnosis of VAP)
  • Number of Participants With Microbiological Outcome(28 days after diagnosis of VAP)
  • Duration of Hospital Stay(Up to 28 days after diagnosis of VAP)
  • Duration of Antimicrobial Treatment(Up to 28 days after diagnosis of VAP)
  • Duration of Mechanical Ventilation(Up to 28 days after diagnosis of VAP)
  • Number of Antibiotic Free Days(Up to 28 days after diagnosis of VAP)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

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