Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methicillin-Resistant Staphylococcus Aureus (MRSA); Hospital-Acquired Pneumonia
Intervention: Linezolid (Drug); Vancomycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Percentage of Participants With Clinical Success
Secondary outcome: Number of Participants With Microbiological OutcomeDuration of Hospital Stay Duration of Intensive Care Unit (ICU) Stay Duration of Mechanical Ventilation Duration of Antimicrobial Treatment Number of Antibiotic Free Days
Detailed description:
Non-randomized, retrospective, observational study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2008
Last updated: June 9, 2014
|