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

NCT ID: NCT00414193

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Bacteremia; AmpC Beta-lactamase

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Health Sciences Foundation

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Yohei Doi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David L Paterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pitttsburgh

Yohei Doi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB#0611104

Identifier Type: -

Identifier Source: org_study_id