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

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. Identifier: NCT00877708
Recruitment Status : Active, not recruiting
First Posted : April 8, 2009
Last Update Posted : June 9, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Yohei Doi, University of Pittsburgh

Brief Summary:

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.

Condition or disease
E Coli Infections

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol
Study Start Date : March 2009
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. dead or alive [ Time Frame: end of study ]
    health status

Biospecimen Retention:   Samples Without DNA
Biologic samples (isolates) will be under the control of the principal investigator of this research project. All samples provided to the investigator are de-identified 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 investigator on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 839, 3550 Terrace Street. At no time with the research investigators have access to any patient identifers. Medical record information and bacteria samples from facilities outside of UPMC will be provided to the PI de-identified. At not time will anyone on the research team have access to patient identifiers. All information and bacteria are collected as part of the patient's clinical treatment.

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:   Probability Sample
Study Population
patients with E. coli infections at UPMC

Inclusion Criteria:

  • patients with E. coli infections at UPMC

Exclusion Criteria:

  • not meeting entry criteria

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 identifier (NCT number): NCT00877708

United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Principal Investigator: Yohei Doi, MD University of Pittsburgh

Responsible Party: Yohei Doi, MD, University of Pittsburgh Identifier: NCT00877708     History of Changes
Other Study ID Numbers: IRB#PRO08100393
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Yohei Doi, University of Pittsburgh:
E. Coli

Additional relevant MeSH terms:
Escherichia coli Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents