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

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00475891
Collaborator
(none)
20
Enrollment
1
Location
92
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures
    Study Start Date :
    Apr 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. dead or alive [end of study]

      health status

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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 Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT00475891
    Other Study ID Numbers:
    • PRO07050007
    First Posted:
    May 21, 2007
    Last Update Posted:
    Dec 8, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by University of Pittsburgh
    isolate
    infection
    linezolid

    Study Results

    No Results Posted as of Dec 8, 2014