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Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573235
First Posted: December 14, 2007
Last Update Posted: June 9, 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):
Yohei Doi, University of Pittsburgh
  Purpose
The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes.

Condition
Enterobacteriaceae Infections

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli

Resource links provided by NLM:


Further study details as provided by Yohei Doi, University of Pittsburgh:

Primary Outcome Measures:
  • Review whether ESBL-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated or community-associated. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
All samples provided to the investigators are deidentified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time with the research investigators have access to any patient identifers.

Estimated Enrollment: 300
Study Start Date: October 2007
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Detailed Description:
This is chart review at UPMC. There is no human interaction.
  Eligibility

Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.
Criteria

Inclusion Criteria:

  • All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.
  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): NCT00573235


Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Yohei Doi, MD University of Pittsburgh
  More Information

Responsible Party: Yohei Doi, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00573235     History of Changes
Other Study ID Numbers: PRO07090323
First Submitted: December 12, 2007
First Posted: December 14, 2007
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Yohei Doi, University of Pittsburgh:
isolates
infection
E coli isolates

Additional relevant MeSH terms:
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections