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

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ClinicalTrials.gov Identifier: NCT00573521
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Potoski, University of Pittsburgh

December 12, 2007
December 14, 2007
June 12, 2018
November 2007
June 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00573521 on ClinicalTrials.gov Archive Site
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Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms
Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms
This research will be conducted to determine whether risk factors exist for piperacillin/tazobactam resistance in ESBL organisms.
This is chart review at UPMC. NO human subject interaction will occur.
Observational
Observational Model: Other
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:
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.
Non-Probability Sample
ESBL positive cultures
Enterobacteriaceae Infections
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
Same as current
June 2017
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00573521
PRO07100136
Yes
Not Provided
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Brian Potoski, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Brian Potoski, Pharm D University of Pittsburgh
University of Pittsburgh
June 2018