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| Sponsors and Collaborators: |
University of Pittsburgh Physicians own funding |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00304330 |
Purpose
The information collected will provide insight in to the epidemiology of antibiotic resistance in a transplant compared to a non-transplant population.
Data is needed regarding the date of admission, date of bloodstream infection and location of ward/ICU so trends in the emergence of resistance and antibiotic usage can be detected.
| Condition |
|---|
|
Gram Negative Infection |
| Study Type: | Observational |
| Study Design: | Retrospective |
| Official Title: | Emergence of Gram-Negative Resistance in Blood Culture Isolates of Solid-Organ Transplant Recipients; a Comparative Study With a Non-Transplant Population |
No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | December 2012 |
We need to collect details on the demographics (age, sex etc), underlying conditions, transplant types and immunosuppression, in-hospital antibiotic management and clinical outcomes so that the effect of antibiotic resistance on patient outcome can be measured. We also need to collect microbiology and pathology data to determine the antibiotic susceptibility profile of the involved organisms. The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, prophylactic antimicrobials, physical exam findings, laboratory and radiographical data, empiric antimicrobial usage, microbiological data and resistance patterns, choice of antibiotic once organism identified, suspected source of infection, microbiological and clinical outcomes, laboratory results, demographic information, medications, gender, weight, ethnicity, and past medical history
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
gram negative organisms
Inclusion Criteria:
Contacts and Locations| Contact: David L Paterson, MD | 412-648-6401 | patersond@dom.pitt.edu |
| Contact: Diana Lynn Pakstis, RN, BSN | 412-648-6553 | pakstisdl@dom.pitt.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: David L Paterson, MD 412-648-6401 patersond@dom.pitt.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu | |
| Principal Investigator: David L Paterson, MD | |
| Principal Investigator: | David L Paterson, MD | University of Pittsburgh |
More Information
| Responsible Party: | UPMC ( David Paterson, MD ) |
| Study ID Numbers: | IRB# 0602123 |
| Study First Received: | March 15, 2006 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00304330 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
gram negative infection |
|
Infection |
