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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 Outcome

Duration 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

Page last updated: August 23, 2015

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