Clinical trial NCT00414193: Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase
Official title: Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
AmpC Beta-lactamase
Keywords: AmpC beta-lactamase
Bacteremia
Piperacillin
Tazobactam
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Japan Health Sciences Foundation
First posted: 2006-12-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: positive cultures

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.

Eligibility 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.

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pitttsburgh
name: David L Paterson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Yohei Doi, MD
role: PRINCIPAL_INVESTIGATOR
References: