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An Evaluation Of Respiratory Samples for Staphylococcus Resistance PatternsS (MRSA)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00754273
First received: September 16, 2008
Last updated: March 22, 2011
Last verified: March 2011
History of Changes
  Purpose

To determine the prevalence of MRSA isolates with marginal susceptibility to vancomycin or heteroresistance.


Condition Intervention
Methicillin-resistant Staphylococcal Aureus Pneumonia
 Other: etest susceptability testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation Of Protected Alveolar Lavage (PAL) Staphylococcus Aurues Resistance Patterns

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Determine the prevalence of PAL hetero-VISA within MRSA isolates using vancomycin E-tests and contrast this with E-tests for teicoplanin, linezolid and tigecycline. [ Time Frame: 1 time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the sensitivity and specificity of automated susceptibility testing for PAL MRSA for vancomycin and alternative agents teicoplanin, linezolid and tigecycline by comparing automated sensitivity testing to E-test results. [ Time Frame: 1 time ] [ Designated as safety issue: No ]

Estimated Enrollment: 1250
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
PAL samples collected for pneumonia evaluation
 Other: etest susceptability testing
E-test methodology is performed on all MRSA samples using standardized inoculum (0.5 McFarland) for Tigecycline, Vancomycin, Teicoplanin, and Linezolid. E test is performed using heavy inoculum for Vancomycin and Teicoplanin (2.0 McFarland).

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

One hundred consecutive isolates of MRSA will be analyzed.

Criteria

Inclusion Criteria:

  • Isolates of MRSA from PAL samples

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754273

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Pfizer
Investigators
Principal Investigator: Andrew C. Bernard, M.D. University of Kentucky
  More Information

No publications provided

Responsible Party: Andrew Bernard, M.D., University of Kentucky Medical Center
ClinicalTrials.gov Identifier: NCT00754273     History of Changes
Other Study ID Numbers: 07-0775-P6H
Study First Received: September 16, 2008
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Staphylococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial

ClinicalTrials.gov processed this record on May 21, 2013