Quinolone Resistance in Bloodstream Isolates of Escherichia Coli

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00449735
First received: March 19, 2007
Last updated: August 23, 2012
Last verified: August 2012
  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:

Estimated Enrollment: 500
Study Start Date: March 2007
Estimated Study Completion Date: December 2015
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00449735     History of Changes
Other Study ID Numbers: PRO07030003
Study First Received: March 19, 2007
Last Updated: August 23, 2012
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

Additional relevant MeSH terms:
Bacterial Infections
Infection

ClinicalTrials.gov processed this record on October 23, 2014