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

June 13, 2018 updated by: Yohei Doi, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

positive cultures

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dead or alive
Time Frame: end of study
health status
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Japan Health Sciences Foundation

Investigators

  • Principal Investigator: Yohei Doi, MD, University of Pittsburgh
  • Principal Investigator: David L Paterson, MD, University of Pitttsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2007

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 20, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#0611104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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