Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy
Primary Purpose
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ciprofloxacine
Sponsored by

About this trial
This is an interventional prevention trial for Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion. focused on measuring Prostate,, Infection,, Biopsy,, Antibiotic,, Prophylaxis
Eligibility Criteria
Inclusion Criteria: abnormal digital rectal examination abnormal PSA values To be excluded those patients with: ciprofloxacine contraindication indwelling urethral catheter, positive urine culture, presence of cardiac valve prosthesis, uncontrolled diabetes mellitus, use of antimicrobials in the 7 days prior to biopsy. Urinary endoscopic procedure in the 7 days prior to biopsy coagulation defect Renal insufficiency Hepatic insufficiency
Sites / Locations
- Poitiers Hospital University
Outcomes
Primary Outcome Measures
Bacteriuria five days after prostate biopsy
Secondary Outcome Measures
- Clinically diagnosed infectious complications
- Other complications related to the procedure
Full Information
NCT ID
NCT00294749
First Posted
February 19, 2006
Last Updated
January 26, 2009
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00294749
Brief Title
Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy
Official Title
Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether long antibiotic prophylactic is more effective than a short traitement in infective complications for prostate biopsy
Detailed Description
Prophylactic antibiotic is used to minimize the infective complications risk following transrectal biopsy of the prostate.
The majority of works points to the need of antibiotic prophylaxis previously to transrectal prostate biopsy. However, there is a lot of controversy and diversity of therapeutic schemes in the literature concerning the ideal drug to be used and the time employed for infectious prophylaxis.
The objective of this randomised study was to assess 2 different schemes of antimicrobial prophylaxis, aiming to determine the difference in infective complications with a single dose of ciprofloxacin 2 hours before the procedure vs. ciprofloxacin for 3 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.
Keywords
Prostate,, Infection,, Biopsy,, Antibiotic,, Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacine
Primary Outcome Measure Information:
Title
Bacteriuria five days after prostate biopsy
Secondary Outcome Measure Information:
Title
- Clinically diagnosed infectious complications
Title
- Other complications related to the procedure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
abnormal digital rectal examination
abnormal PSA values
To be excluded those patients with:
ciprofloxacine contraindication
indwelling urethral catheter,
positive urine culture,
presence of cardiac valve prosthesis,
uncontrolled diabetes mellitus,
use of antimicrobials in the 7 days prior to biopsy.
Urinary endoscopic procedure in the 7 days prior to biopsy
coagulation defect
Renal insufficiency
Hepatic insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irani Jacques, professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poitiers Hospital University
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy
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