We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00915213
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : December 19, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Bacterial Infection

Study Design

Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Fluoroquinolone Resistant Enterobacteraciae in Patients Undergoing Repeat Ultrasound Guided Prostate Biopsy
Study Start Date : October 2008
Primary Completion Date : June 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Repeat Prostate Biopsy
Men who undergo repeat prostate biopsy


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Rectal Swab

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: June 5, 2009    Key Record Dates
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