Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol

NCT ID: NCT00877708

Last Updated: 2018-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to review patients with E. coli infections at UPMC from September 1, 2008 to August 31, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes and determine their clinical outcomes.

The specific aims of this study are to:

1. Review whether cephalosporin-resistant E. coli infections are hospital-acquired, healthcare-associated or community-associated.
2. Determine the clinical outcome of the patients according to the antibiotics given.

Detailed Description

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De-identified data will be obtained by the honest broker for the requested time period. In addtion, the honest broker will work with the microbiology laboratory to collect the isolates associated with the de-identified data. All data and samples will be de-identified. De-identified data will be given to the nurse coordinator to complete the case report forms and enter the data into the password protected database and the de-identified isolates will be stored and analyzed on the 8th floor Scaife in Dr. Yohie Doi's laboratory.

Conditions

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E Coli Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients with E. coli infections at UPMC

Exclusion Criteria

* not meeting entry criteria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Yohei Doi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yohei Doi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#PRO08100393

Identifier Type: -

Identifier Source: org_study_id

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