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

Completed

• Conditions: Hospital-Acquired Pneumonia; Methicillin-Resistant Staphylococcus Aureus (MRSA)
• Interventions: Drug: Linezolid; Drug: Vancomycin

• Registration Number: NCT01561469
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-06
• Results First Submitted: 2014-06-09
• Results First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Results First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Linezolid observational cohort	Linezolid	-
Vancomycin observational cohort	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Success	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 Outcome Measures

Name	Time	Method
Duration of Intensive Care Unit (ICU) Stay	Up to 28 days after diagnosis of VAP	Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.
Number of Participants With Microbiological Outcome	28 days after diagnosis of VAP	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).
Duration of Hospital Stay	Up to 28 days after diagnosis of VAP	Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.
Duration of Antimicrobial Treatment	Up to 28 days after diagnosis of VAP
Duration of Mechanical Ventilation	Up to 28 days after diagnosis of VAP	Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.
Number of Antibiotic Free Days	Up to 28 days after diagnosis of VAP