Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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


Study summary:

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


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


Study is Available At:


Original ID:

PRO07100136


NCT ID:

NCT00573521


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

450


Enrollment Type:

Actual


Overall Contact Information

Official Name:Brian Potoski, Pharm D
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:November 2007
Completion Date:June 2017
Completion Type:Actual
Primary Completion Date:June 2017
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 11, 2018
First Received Date:December 12, 2007

Study Outcomes

Outcome Type: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
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh

Samples and Retentions

Sample 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.
Study Population: ESBL positive cultures
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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