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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00573521
First received: December 12, 2007
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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


Condition
Enterobacteriaceae Infections

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 450
Study Start Date: November 2007
Estimated Study Completion Date: December 2013
Detailed Description:

This is chart review at UPMC. NO human subject interaction will occur.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ESBL positive cultures

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients < 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573521

Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Brian Potoski, Pharm D University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00573521     History of Changes
Other Study ID Numbers: PRO07100136
Study First Received: December 12, 2007
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
ESBL positive cultures

Additional relevant MeSH terms:
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Piperacillin
Piperacillin-tazobactam combination product
Penicillanic Acid
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014