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Quinolone Resistance in Bloodstream Isolates of Escherichia Coli

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: NCT00449735
  Purpose

This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of E. coli. Additionally, the adequacy of empiric antibiotic therapy for E. coli bloodstream infections will be assessed. Finally, outcome will be recorded - this is all-cause mortality at 28 days from the time of the first positive blood culture. Hypothesis: Ciprofloxacin resistant strains are associated with admission from nursing home and with prior quinolone use.


Condition
Bacterial Infections

MedlinePlus related topics:   Bacterial Infections   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Retrospective
Official Title:   Quinolone Resistance in Bloodstream Isolates of Escherichia Coli

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   500
Study Start Date:   March 2007

Detailed Description:

The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

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

Study Population

E coli positive cultures


Criteria

Inclusion Criteria:

Clinical information is collected by chart review of "case" and "control" patients.

A "case A" patient is defined as follows:

  • One or more blood cultures are positive for E. coli. The organism is ciprofloxacin resistant.

A "case B" patient is defined as follows:

  • One or more blood cultures are positive for E. coli. The organism is ciprofloxacin susceptible. Additionally, 4 controls who are in hospital at the same time as cases will be selected for each case.

Exclusion Criteria:

  • If they do not meet inclusion criteria
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449735

Contacts
Contact: David L Paterson, MD     412-648-6401     patersond@dom.pitt.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: David L Paterson, MD     412-648-6401     patersond@dom.pitt.edu    
      Contact: Diana Lynn Pakstis, RN, BSN     412-648-6553     pakstisdl@dom.pitt.edu    
      Sub-Investigator: Yohei Doi, MD            
      Principal Investigator: David L Paterson, MD            

Sponsors and Collaborators
University of Pittsburgh

Investigators
Principal Investigator:     David L Paterson, MD     University of Pittsburgh    
  More Information


Responsible Party:   UPMC ( David Paterson, MD )
Study ID Numbers:   PRO07030003
First Received:   March 19, 2007
Last Updated:   October 3, 2008
ClinicalTrials.gov Identifier:   NCT00449735
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
positive isolates  
ecoli  
blood cultures  
positive cultures for ecoli  
blood stream infections  

Study placed in the following topic categories:
Bacterial Infections

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 31, 2008




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