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| Sponsors and Collaborators: |
University of Pittsburgh Merck |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00394784 |
Purpose
This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for gram-negative blood stream infections based on known pharmacodynamic parameters.
| Condition |
|---|
|
Gram-Negative Bacterial Infections |
| Study Type: | Observational |
| Study Design: | Retrospective |
| Official Title: | Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-Negative Bloodstream Isolates |
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: | 100 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2012 |
Bacterial cultures will be ordered in the normal clinical course of the management of patients in the liver transplant ICU by the medical team. These cultures are then processed by the clinical Microbiology laboratory in the normal manner. If these cultures grow a Gram-negative bacteria, they are eligible for this study. Typically the clinical Microbiology laboratory saves these bacteria for a period of time after the final microbiology report. At this time, unless asked otherwise, the bacteria will be placed in biohazardous waste containers for proper disposal. If these cultures have grown a Gram-negative bacteria, they are eligible for this study, and will not be disposed of but will be given to the investigators without identifiers for this study. The antibiotic susceptibility of these organisms will be tested by the investigators in a separate research laboratory. Mechanisms of antibiotic resistance may also be assessed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
positive gram negative bacteria isolates
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Brian Potoski, PharmD | 412-648-6401 | potoskiba@upmc.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: Brian Potoski, PharmD 412-648-6401 potoskiba@upmc.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu | |
| Sub-Investigator: David L Paterson, MD | |
| Principal Investigator: Brian Potoski, PharmD | |
| Principal Investigator: | Brian Potoski, PharmD | University of Pittsburgh |
More Information
| Responsible Party: | UPMC ( Brian Potoski, Pharm D ) |
| Study ID Numbers: | IRB#0608120 |
| Study First Received: | October 30, 2006 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00394784 |
| Health Authority: | United States: Institutional Review Board |
|
gram negative bacteria culture infection |
|
Bacterial Infections Gram-Negative Bacterial Infections |
|
Infection |
