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

NCT00414193 | Completed DMC

• 1 other identifier: IRB#0611104
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteremia; AmpC Beta-lactamase

Keywords

AmpC beta-lactamase; Bacteremia; Piperacillin; Tazobactam

Outcome Measures

Primary Outcomes (1)

• dead or alive

  health status

  end of study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

positive cultures

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Japan Health Sciences Foundation: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David L Paterson, MD

  University of Pitttsburgh

  PRINCIPAL INVESTIGATOR

• Yohei Doi, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: February 1, 2007
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

US (1)