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Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414193
First Posted: December 21, 2006
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Japan Health Sciences Foundation
Information provided by (Responsible Party):
Yohei Doi, University of Pittsburgh
  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

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase

Resource links provided by NLM:


Further study details as provided by Yohei Doi, University of Pittsburgh:

Primary Outcome Measures:
  • dead or alive [ Time Frame: end of study ]
    health status


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: 1000
Study Start Date: February 2007
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414193


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
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: Yohei Doi, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00414193     History of Changes
Other Study ID Numbers: IRB#0611104
First Submitted: December 19, 2006
First Posted: December 21, 2006
Last Update Posted: June 9, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Tazobactam
Piperacillin
Piperacillin, tazobactam drug combination
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action