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

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
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 ] [ 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).

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

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

Additional relevant MeSH terms:

Pneumonia
Pneumonia, Staphylococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial

ClinicalTrials.gov processed this record on February 09, 2012