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Sponsors and Collaborators: |
University of Pittsburgh Japan Health Sciences Foundation |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00414193 |
Nosocomial bloodstream infections are important causes of morbidity and mortality caused by AmpC beta-lactamase-producing Enterobacteriaceae. The information collected will optimize the management of patients with nosocomial bloodstream infections.
Condition |
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Bacteremia AmpC Beta-Lactamase |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase |
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: | February 2007 |
Estimated Study Completion Date: | December 2012 |
The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
positive cultures
Inclusion Criteria:
Clinical information is collected by chart review of "case" and "control" patients. A "case" patient is defined as follows:
A "control" patient is defined as follows:
Contact: David L Paterson, MD | 412-648-6401 | patersond@dom.pitt.edu |
Contact: Yohei Doi, MD | 412-648-6401 | doiy@dom.pitt.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Diana Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu | |
Contact: Mary Ellen Carey, RN, BSN 412648-6453 cheswickm@dom.pitt.edu | |
Principal Investigator: David L Paterson, MD |
Principal Investigator: | David L Paterson, MD | University of Pitttsburgh |
Principal Investigator: | Yohei Doi, MD | University of Pittsburgh |
Responsible Party: | UPMC ( David Paterson, MD ) |
Study ID Numbers: | IRB#0611104 |
Study First Received: | December 19, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00414193 |
Health Authority: | United States: Institutional Review Board |
AmpC beta-lactamase Bacteremia Piperacillin Tazobactam |
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis Penicillanic Acid Bacteremia |
Tazobactam Piperacillin Piperacillin-tazobactam combination product Inflammation |
Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |