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Quinolone Resistance in Bloodstream Isolates of Escherichia Coli

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449735
First Posted: March 21, 2007
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  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

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • dead or alive [ Time Frame: end of study ]
    health status


Enrollment: 500
Actual Study Start Date: March 2007
Study Completion Date: June 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449735


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David L Paterson, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00449735     History of Changes
Other Study ID Numbers: PRO07030003
First Submitted: March 19, 2007
First Posted: March 21, 2007
Last Update Posted: June 26, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Bacterial Infections