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

Sponsors and Collaborators:	University of Kentucky 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

MedlinePlus related topics: Pneumonia

Drug Information available for: Tigecycline Vancomycin Linezolid Vancomycin hydrochloride Teicoplanin

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

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).

Eligibility

Study Population

One hundred consecutive isolates of MRSA will be analyzed.

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754273

Contacts

Contact: Andrew C Bernard

859-323-6346

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:	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
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Teicoplanin
Respiratory Tract Infections
Respiratory Tract Diseases
Tigecycline

Lung Diseases
Vancomycin
Linezolid
Pneumonia

ClinicalTrials.gov processed this record on January 13, 2009