Antibiotic Resistant Community-Acquired E. Coli

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00298103
First received: February 27, 2006
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to review patients with E. coli infections at UPMC from January 1, 2004 to December 31, 2005 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community.


Condition
E Coli Infection

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Antibiotic Resistant Community-Acquired E. Coli

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.


Estimated Enrollment: 1000
Study Start Date: February 2006
Estimated Study Completion Date: December 2015
Detailed Description:

The following variables will be followed: age, sex, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization or nursing home admission, receipt of outpatient dialysis 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with e coli infections

Criteria

Inclusion Criteria:

  • ll patients with E. coli infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC-P who had no established risk factors for infection with an antibiotic resistant organism.

Established risk factors are defined as:

  • Isolation of the organism two or more days after admission for hospitalization OR A history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date
  • OR The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture
  • OR Previous isolation of an antibiotic resistant organism
  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: NCT00298103

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: NCT00298103     History of Changes
Other Study ID Numbers: IRB# 0602065
Study First Received: February 27, 2006
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Antibiotic resistant
Infection

Additional relevant MeSH terms:
Escherichia coli Infections
Infection
Bacterial Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014