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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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on March 03, 2015