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

NCT00877708 | Completed DMC

• 1 other identifier: IRB#PRO08100393
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

E Coli Infections

Keywords

E. Coli; isolates

Outcome Measures

Primary Outcomes (1)

• dead or alive

  health status

  end of study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with E. coli infections at UPMC

You may qualify if:

• patients with E. coli infections at UPMC

You may not qualify if:

• not meeting entry criteria

Sponsors & Collaborators

• University of Pittsburgh: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Yohei Doi, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

US (1)