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Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915213
First Posted: June 5, 2009
Last Update Posted: December 19, 2016
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. Read our disclaimer for details.
Collaborator:
Copan Diagnostics, Inc.
Information provided by (Responsible Party):
Thomas E. Ahlering, University of California, Irvine
  Purpose
The purpose of this study is to discover how often certain bacteria are found in the rectum at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of importance because they can cause serious infection. Antibiotics that urologists commonly use to prevent these bacteria from causing infection are no longer effective. Many physicians around the world are noting increased infections with antibiotic resistant bacteria. Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics, certain patients are being readmitted to the hospital with a serious infection. In order to study the incidence of these particular bacteria, the best method is to culture the bacteria at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy of the prostate. Once the incidence of these bacteria is known we may take steps to prevent the serious infections that occur as a result of prostate biopsy.

Condition
Bacterial Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Fluoroquinolone Resistant Enterobacteraciae in Patients Undergoing Repeat Ultrasound Guided Prostate Biopsy

Resource links provided by NLM:


Further study details as provided by Thomas E. Ahlering, University of California, Irvine:

Biospecimen Retention:   Samples Without DNA
Rectal Swab

Enrollment: 136
Study Start Date: October 2008
Study Completion Date: December 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Repeat Prostate Biopsy
Men who undergo repeat prostate biopsy

  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:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men undergoing repeat prostate biopsy
Criteria

Inclusion Criteria:

  • adult males
  • repeat prostate biopsy

Exclusion Criteria:

  • first time prostate biopsy
  • minors
  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): NCT00915213


Locations
United States, California
Kaiser Permanente
Irvine, California, United States, 92618
Long Beach Veteran Affairs
Long Beach, California, United States, 90822
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Copan Diagnostics, Inc.
Investigators
Principal Investigator: Atreya Dash, MD University of California, Irvine
  More Information

Responsible Party: Thomas E. Ahlering, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00915213     History of Changes
Other Study ID Numbers: 2008-6418
First Submitted: June 3, 2009
First Posted: June 5, 2009
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Thomas E. Ahlering, University of California, Irvine:
E. Coli
Prostate Biopsy

Additional relevant MeSH terms:
Bacterial Infections