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Sponsors and Collaborators: |
University of California, Irvine Hardy Diagnostics Copan Diagnostics |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00915213 |
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 |
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Bacterial Infection |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Incidence of Fluoroquinolone Resistant Enterobacteraciae in Patients Undergoing Repeat Ultrasound Guided Prostate Biopsy |
Rectal Swab
Estimated Enrollment: | 300 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Repeat Prostate Biopsy
Men who undergo repeat prostate biopsy
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Men undergoing repeat prostate biopsy
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, Irvine Medical Center | |
Orange, California, United States, 92868 | |
Long Beach Veteran Affairs | |
Long Beach, California, United States, 90822 | |
Kaiser Permanente | |
Irvine, California, United States, 92618 |
Principal Investigator: | Atreya Dash, MD | University of California, Irvine |
Responsible Party: | University of California, Irvine ( Atreya Dash, M.D. ) |
Study ID Numbers: | 2008-6418 |
Study First Received: | June 3, 2009 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00915213 History of Changes |
Health Authority: | United States: Institutional Review Board |
E. Coli Prostate Biopsy |
Bacterial Infections Anti-Bacterial Agents Fluoroquinolones |
Bacterial Infections Infection |