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

NCT01561469 | Completed Results

• 1 other identifier: A5951168
• Study Type: observational
• Target: 188
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Methicillin-Resistant Staphylococcus Aureus (MRSA); Hospital-Acquired Pneumonia

Keywords

Linezolid; Vancomycin; Ventilator-Associated Pneumonia; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Success

  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.

  14 days after diagnosis with VAP or hospital discharge, whichever occurred first

Secondary Outcomes (6)

• 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 Intensive Care Unit (ICU) Stay

  Up to 28 days after diagnosis of VAP

• Duration of Mechanical Ventilation

  Up to 28 days after diagnosis of VAP

• Duration of Antimicrobial Treatment

  Up to 28 days after diagnosis of VAP

Study Arms (2)

Linezolid observational cohort

Drug: Linezolid

Vancomycin observational cohort

Drug: Vancomycin

Interventions

Linezolid DRUG

Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.

Also known as: Zyvox

Linezolid observational cohort

Vancomycin DRUG

Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.

Also known as: Vancocin

Vancomycin observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients not meeting enrollment criteria.

Sponsors & Collaborators

• Pfizer: lead
• University of Louisville: collaborator
• Henry Ford Hospital: collaborator
• Summa Health System: collaborator
• Sparrow Health System: collaborator
• Jackson Health System: collaborator

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Respiratory Tract Infections

Interventions

Linezolid; Vancomycin

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Prioritization of endpoints as primary or secondary was not specified in protocol and was based on study team's inputs.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: November 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 10, 2014
• Results First Posted: July 10, 2014

Record last verified: 2014-06