Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol
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.
E Coli Infections
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol|
- dead or alive [ Time Frame: end of study ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877708
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Yohei Doi, MD||UPMC|