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

E Coli Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877708
• Other study ID #: IRB#PRO08100393
• Status: Completed
• Start date: March 2009
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with E. coli infections at UPMC

Exclusion Criteria:

• not meeting entry criteria

Related Conditions & MeSH terms

• E Coli Infections
• Escherichia coli Infections

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dead or alive	health status	end of study