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

NCT00915213 | Completed

• 1 other identifier: 2008-6418
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 3

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.

Conditions

Bacterial Infection

Keywords

E. Coli; Prostate Biopsy

Study Arms (1)

Repeat Prostate Biopsy

Men who undergo repeat prostate biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men undergoing repeat prostate biopsy

You may qualify if:

• adult males
• repeat prostate biopsy

You may not qualify if:

• first time prostate biopsy
• minors

Sponsors & Collaborators

• University of California, Irvine: lead
• Copan Diagnostics, Inc.: collaborator

Study Sites (3)

Kaiser Permanente

Irvine, California, 92618, United States

Location

Long Beach Veteran Affairs

Long Beach, California, 90822, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rectal Swab

MeSH Terms

Conditions

Bacterial Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections

Study Officials

• Atreya Dash, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: October 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

US (3)