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

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ClinicalTrials.gov Identifier: NCT00754273
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : March 23, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Kentucky

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To determine the prevalence of MRSA isolates with marginal susceptibility to vancomycin or heteroresistance.

Condition or disease Intervention/treatment
Methicillin-resistant Staphylococcal Aureus Pneumonia Other: etest susceptability testing

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Study Design
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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation Of Protected Alveolar Lavage (PAL) Staphylococcus Aurues Resistance Patterns
Study Start Date : September 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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).


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections