Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures
December 5, 2014 updated by: University of Pittsburgh
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
isolates for rectal surveillance
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dead or alive
Time Frame: end of study
|
health status
|
end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Potoski, Pharm D, University of Pittsburgh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
May 17, 2007
First Submitted That Met QC Criteria
May 18, 2007
First Posted (Estimate)
May 21, 2007
Study Record Updates
Last Update Posted (Estimate)
December 8, 2014
Last Update Submitted That Met QC Criteria
December 5, 2014
Last Verified
December 1, 2014
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.