Antibiotic Resistant Community-Acquired E. Coli - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	Physicians own funding
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00298103

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 Antibiotic Resistant

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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 2012

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

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

Physicians own funding

Investigators

Principal Investigator:

David L Paterson, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	UPMC ( David Paterson, MD )
Study ID Numbers:	IRB# 0602065
Study First Received:	February 27, 2006
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00298103 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Antibiotic resistant
Infection

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Therapeutic Uses

Enterobacteriaceae Infections
Escherichia coli Infections
Infection
Pharmacologic Actions
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on November 30, 2009