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

NCT ID: NCT00915213

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bacterial Infection

Keywords

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E. Coli Prostate Biopsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Repeat Prostate Biopsy

Men who undergo repeat prostate biopsy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* adult males
* repeat prostate biopsy

Exclusion Criteria

* first time prostate biopsy
* minors
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Copan Diagnostics, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Thomas E. Ahlering

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atreya Dash, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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Kaiser Permanente

Irvine, California, United States

Site Status

Long Beach Veteran Affairs

Long Beach, California, United States

Site Status

University of California, Irvine Medical Center

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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2008-6418

Identifier Type: -

Identifier Source: org_study_id