An Evaluation Of Respiratory Samples for Staphylococcus Resistance PatternsS - Full Text View

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

This study is not yet open for participant recruitment.

Verified by University of Kentucky, September 2008

First Received: September 16, 2008 No Changes Posted

Sponsor:	University of Kentucky
Collaborator:	Pfizer
Information provided by:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00754273

Purpose

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

Condition	Intervention
MRSA Pneumonia	Other: etest susceptability testing

Study Type:	Observational
Study Design:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1250
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	July 2009 (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).

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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

Contacts

Contact: Andrew C Bernard

859-323-6346

acbern00@uky.edu

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

Additional relevant MeSH terms:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on November 20, 2009