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Determination of Genetic Relatedness of Linezolid-Resistant VRE Surveillance Cultures

This study is currently recruiting participants.
Verified by University of Pittsburgh, October 2008

Sponsored by: 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 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

MedlinePlus related topics:   Antibiotics   

ChemIDplus related topics:   Linezolid   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Retrospective
Official Title:   Determination of Genetic Relatedness of Linezolid-Resistant VRE Surveillance Cultures

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   20
Study Start Date:   April 2007

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

Contacts
Contact: Brian Potoski, Pharm D     412-648-6487     potoskiba@upmc.edu    
Contact: Diana Lynn Pakstis, RN, BSN     412-648-6553     pakstisdl@dom.pitt.edu    

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center     Recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Contact: Brian Potoski, Pharm D     412-648-6487     potoskiba@upmc.edu    
      Contact: Diana Lynn Pakstis, RN, BSN     412-648-6553     pakstisdl@dom.pitt.edu    
      Principal Investigator: Brian Potoski, Pharm D            

Sponsors and Collaborators
University of Pittsburgh

Investigators
Principal Investigator:     Brian Potoski, Pharm D     University of Pittsburgh    
  More Information


Responsible Party:   UPMC ( Brian Potoski, Pharm D )
Study ID Numbers:   PRO07050007
First Received:   May 17, 2007
Last Updated:   October 3, 2008
ClinicalTrials.gov Identifier:   NCT00475891
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
isolate  
infection  
linezolid  

Study placed in the following topic categories:
Linezolid

Additional relevant MeSH terms:
Protein Synthesis Inhibitors
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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