Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures - Full Text View

Sponsor:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00475891

Purpose

The study will help in identifying the best empiric antibiotic option for Linezolid resistant Vancomycin-resistant Enterococci (VRE) infections. This research is important because it allows the determination of resistance rates to antibiotics that may not be frequently tested to by the clinical microbiology laboratory at UPMC-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for Linezolid-resistant VRE infections.

Condition
Isolate Linezolid

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Linezolid Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Estimated Enrollment:	20
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2013
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

After 20 linezolid-resistant VRE isolates are identified, genetic relatedness will be determined using a method known as Pulse-field gel electrophoresis (PFGE). No patient related data will accompany these isolates, nor will any related identifiers. These isolates will be tested using standardized susceptibility methods. We will then grow each isolate and test via approved laboratory standards (E-test, AB Biodisk, Stockholm, Sweden) to the drug linezolid. Those determined to be resistant using this approved methodology will be saved until 20 isolates are identified. For resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

isolates for rectal surveillance

Criteria

Inclusion Criteria:

Dr. Harrison's laboratory collected the rectal surveillance isolates for infection control purposes. The isolates will be from January 1, 2006 to December 31, 2006.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475891

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Brian Potoski, Pharm D

University of Pittsburgh

More Information

No publications provided

Responsible Party:	Brian Potoski, Pharm D, UPMC
ClinicalTrials.gov Identifier:	NCT00475891 History of Changes
Other Study ID Numbers:	PRO07050007
Study First Received:	May 17, 2007
Last Updated:	August 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

isolate
infection
linezolid

Additional relevant MeSH terms:

Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012