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Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase
This study is currently recruiting participants.
Verified by University of Pittsburgh, December 2008
Sponsors and Collaborators: University of Pittsburgh
Japan Health Sciences Foundation
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00414193
  Purpose

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
Bacteremia
AmpC Beta-Lactamase

Drug Information available for: Piperacillin Piperacillin sodium Tazobactam
U.S. FDA Resources
Study Type: Observational
Study Design: Retrospective
Official Title: Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

positive cultures

Criteria

Inclusion Criteria:

  • Clinical information is collected by chart review of "case" and "control" patients. A "case" patient is defined as follows:

    • One or more blood cultures are positive for E. cloacae, E. aerogenes, C. freundii, S. marcescens or M. morganii.
    • The patient received piperacillin/tazobactam as the initial empiric therapy.
    • The organism was susceptible to piperacillin/tazobactam.
  • A "control" patient is defined as follows:

    • One or more blood cultures are positive for E. cloacae, E. aerogenes, C. freundii, S. marcescens or M. morganii.
    • The patient received a carbapenem or fluoroquinolone antimicrobial as the initial empiric therapy.
    • The organism was susceptible to the empiric regimen.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414193

Contacts
Contact: David L Paterson, MD 412-648-6401 patersond@dom.pitt.edu
Contact: Yohei Doi, MD 412-648-6401 doiy@dom.pitt.edu

Locations
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            
Sponsors and Collaborators
University of Pittsburgh
Japan Health Sciences Foundation
Investigators
Principal Investigator: David L Paterson, MD University of Pitttsburgh
Principal Investigator: Yohei Doi, MD University of Pittsburgh
  More Information

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

Keywords provided by University of Pittsburgh:
AmpC beta-lactamase
Bacteremia
Piperacillin
Tazobactam

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Bacterial Infections
Sepsis
Penicillanic Acid
Bacteremia
Tazobactam
Piperacillin
Piperacillin-tazobactam combination product
Inflammation

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009