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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00754273

First Posted: September 17, 2008

Last Update Posted: March 23, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Pfizer

Information provided by:

University of Kentucky

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 ]

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 ]


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).

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Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	September 16, 2008
First Posted:	September 17, 2008
Last Update Posted:	March 23, 2011
Last Verified:	March 2011

Additional relevant MeSH terms:


Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

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