Clinical trial NCT01561469: Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methicillin-Resistant Staphylococcus Aureus (MRSA)
Hospital-Acquired Pneumonia
Keywords: Linezolid
Vancomycin
Ventilator-Associated Pneumonia
Respiratory Tract Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: University of Louisville
name: Henry Ford Hospital
name: Summa Health System
name: Sparrow Health System
name: Jackson Health System
First posted: 2012-03-23
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Clinical Success
timeFrame: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first
Secondary outcomes:
measure: Number of Participants With Microbiological Outcome
timeFrame: 28 days after diagnosis of VAP
measure: Duration of Hospital Stay
timeFrame: Up to 28 days after diagnosis of VAP
measure: Duration of Intensive Care Unit (ICU) Stay
timeFrame: Up to 28 days after diagnosis of VAP
measure: Duration of Mechanical Ventilation
timeFrame: Up to 28 days after diagnosis of VAP
measure: Duration of Antimicrobial Treatment
timeFrame: Up to 28 days after diagnosis of VAP
measure: Number of Antibiotic Free Days
timeFrame: Up to 28 days after diagnosis of VAP
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: