Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms
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Purpose
This research will be conducted to determine whether risk factors exist for piperacillin/tazobactam resistance in ESBL organisms.
| Condition |
|---|
|
Enterobacteriaceae Infections |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms |
- This research will help to identify risk factors for resistance to an antibiotic that is commonly used in the empiric treatment of critically ill patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
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: | 450 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2013 |
This is chart review at UPMC. NO human subject interaction will occur.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
ESBL positive cultures
Inclusion Criteria:
- Clinical information is collected by chart review of "case" and "control" patients.
- A "case A" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam resistant.
- A "case B" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam susceptible.
- Additionally, 1 control patient in the hospital at the same time as the case patients will be randomly selected for each case and are not in either case group.
Exclusion Criteria:
- Patients < 18 years of age
Contacts and Locations| United States, Pennsylvania | |
| UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Brian Potoski, Pharm D | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00573521 History of Changes |
| Other Study ID Numbers: | PRO07100136 |
| Study First Received: | December 12, 2007 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
ESBL positive cultures |
Additional relevant MeSH terms:
|
Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Piperacillin Piperacillin-tazobactam combination product Penicillanic Acid Tazobactam |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013