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

This study is currently recruiting participants.
Verified June 2017 by Brian Potoski, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573521
First Posted: December 14, 2007
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Potoski, University of Pittsburgh
  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: Observational Model: Other
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 Brian Potoski, 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 ]

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 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Detailed Description:
This is chart review at UPMC. NO human subject interaction will occur.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573521


Contacts
Contact: Brian Potoski, Pharm D 412-648-6401 potoskiba@dom.pitt.edu
Contact: Diana Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu

Locations
United States, Pennsylvania
UPMC Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Brian Potoski, Pharm D    412-648-6601    potoba@upmc.edu   
Contact: Diana Lynn Pakstis, RN, BSN    412-648-6553    dlp5@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Brian Potoski, Pharm D University of Pittsburgh
  More Information

Responsible Party: Brian Potoski, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00573521     History of Changes
Other Study ID Numbers: PRO07100136
First Submitted: December 12, 2007
First Posted: December 14, 2007
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by Brian Potoski, University of Pittsburgh:
ESBL positive cultures

Additional relevant MeSH terms:
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tazobactam
Piperacillin
Piperacillin, tazobactam drug combination
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action