Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms

NCT00573521 | Completed DMC

• 1 other identifier: PRO07100136
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This research will be conducted to determine whether risk factors exist for piperacillin/tazobactam resistance in ESBL organisms.

Conditions

Enterobacteriaceae Infections

Keywords

ESBL positive cultures

Outcome Measures

Primary Outcomes (1)

• This research will help to identify risk factors for resistance to an antibiotic that is commonly used in the empiric treatment of critically ill patients.

  2 years

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

ESBL positive cultures

You may qualify if:

• Clinical information is collected by chart review of "case" and "control" patients.
• A "case A" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam resistant.
• A "case B" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam susceptible.
• Additionally, 1 control patient in the hospital at the same time as the case patients will be randomly selected for each case and are not in either case group.

You may not qualify if:

• Patients \< 18 years of age

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC

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

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Brian Potoski, Pharm D

  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: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

US (1)