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| Sponsors and Collaborators: |
University of Pittsburgh Merck |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00877708 |
Purpose
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:
| Condition |
|---|
|
E. Coli Infection |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol |
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.
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
patients with E. coli infections at UPMC
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yohei Doi, MD | 412-648-9445 | doiy@dom.pitt.edu |
| Contact: Diana Lynn Pakstis, RN, BSN | 412-648-6553 | pakstisdl@dom.pitt.edu |
| United States, Pennsylvania | |
| UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Yohei Doi, MD 412-648-9445 doiy@dom.pitt.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu | |
| Principal Investigator: Yohei Doi, MD | |
| Principal Investigator: | Yohei Doi, MD | UPMC |
More Information
| Responsible Party: | UPMC ( Yohei Doi, MD ) |
| Study ID Numbers: | IRB#PRO08100393 |
| Study First Received: | April 7, 2009 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00877708 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
E. Coli isolates |
|
Bacterial Infections Anti-Bacterial Agents Cephalosporins Enterobacteriaceae Infections |
Escherichia coli Infections Cefixime Gram-Negative Bacterial Infections |
|
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Cephalosporins Therapeutic Uses |
Enterobacteriaceae Infections Escherichia coli Infections Infection Pharmacologic Actions Gram-Negative Bacterial Infections |
