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NCT00915213 Clinical Trial

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

Bacterial Infection Clinical Trial

Official title:
Incidence of Fluoroquinolone Resistant Enterobacteraciae in Patients Undergoing Repeat Ultrasound Guided Prostate Biopsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00915213
Other study ID # 2008-6418
Secondary ID
Status Completed
Phase N/A
First received June 3, 2009
Last updated December 16, 2016
Start date October 2008
Est. completion date December 2014

Study information
Verified date December 2016
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 136
Est. completion date December 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult males

- repeat prostate biopsy

Exclusion Criteria:

- first time prostate biopsy

- minors

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Kaiser Permanente Irvine California
United States Long Beach Veteran Affairs Long Beach California
United States University of California, Irvine Medical Center Orange California

Sponsors (2)
Lead Sponsor Collaborator
University of California, Irvine Copan Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

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