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

Linezolid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475891
• Other study ID #: PRO07050007
• Status: Completed
• Phase: N/A
• First received: May 17, 2007
• Last updated: December 5, 2014
• Start date: April 2007
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Isolate
• Linezolid

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dead or alive	health status	end of study	No