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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hardy Diagnostics
Copan Diagnostics
Information provided by (Responsible Party):
Victor Huynh, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00915213
First received: June 3, 2009
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Biospecimen Retention:   Samples Without DNA

Rectal Swab


Estimated Enrollment: 300
Study Start Date: October 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Repeat Prostate Biopsy
Men who undergo repeat prostate biopsy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Hardy Diagnostics
Copan Diagnostics
Investigators
Principal Investigator: Atreya Dash, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Victor Huynh, Urology Account Contact, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00915213     History of Changes
Other Study ID Numbers: 2008-6418
Study First Received: June 3, 2009
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on June 17, 2013