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Clinical Trials/NCT00414193
NCT00414193CompletedNot Applicable

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

University of Pittsburgh1 site in 1 country1,000 target enrollmentStarted: February 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,000
Locations
1
Primary Endpoint
dead or alive

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

dead or alive

Time Frame: end of study

health status

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yohei Doi

MD

University of Pittsburgh

Study Sites (1)

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