- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877708
Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol
June 13, 2018 updated by: Yohei Doi, University of Pittsburgh
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:
- Review whether cephalosporin-resistant E. coli infections are hospital-acquired, healthcare-associated or community-associated.
- Determine the clinical outcome of the patients according to the antibiotics given.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with E. coli infections at UPMC
Description
Inclusion Criteria:
- patients with E. coli infections at UPMC
Exclusion Criteria:
- not meeting entry criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dead or alive
Time Frame: end of study
|
health status
|
end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yohei Doi, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2009
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 7, 2009
First Submitted That Met QC Criteria
April 7, 2009
First Posted (Estimate)
April 8, 2009
Study Record Updates
Last Update Posted (Actual)
June 14, 2018
Last Update Submitted That Met QC Criteria
June 13, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#PRO08100393
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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