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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:
Copan Diagnostics, Inc.
Information provided by (Responsible Party):
Thomas E. Ahlering, University of California, Irvine

Tracking Information
First Submitted Date June 3, 2009
First Posted Date June 5, 2009
Last Update Posted Date December 19, 2016
Study Start Date October 2008
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy
Official Title Incidence of Fluoroquinolone Resistant Enterobacteraciae in Patients Undergoing Repeat Ultrasound Guided Prostate Biopsy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Rectal Swab
Sampling Method Non-Probability Sample
Study Population Men undergoing repeat prostate biopsy
Condition Bacterial Infection
Intervention Not Provided
Study Groups/Cohorts Repeat Prostate Biopsy
Men who undergo repeat prostate biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 16, 2016)
136
Original Estimated Enrollment
 (submitted: June 4, 2009)
300
Actual Study Completion Date December 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adult males
  • repeat prostate biopsy

Exclusion Criteria:

  • first time prostate biopsy
  • minors
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00915213
Other Study ID Numbers 2008-6418
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thomas E. Ahlering, University of California, Irvine
Study Sponsor University of California, Irvine
Collaborators Copan Diagnostics, Inc.
Investigators
Principal Investigator: Atreya Dash, MD University of California, Irvine
PRS Account University of California, Irvine
Verification Date December 2016