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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
Poitiers University Hospital
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
February 19, 2006
Last Updated
January 26, 2009
Sponsor
Poitiers University Hospital
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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

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Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

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