Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

Phase 3

Terminated

• Conditions: Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.

• Registration Number: NCT00294749
• Lead Sponsor: Poitiers University Hospital

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

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-19
• Study First Submitted QC: 2006-02-19
• Study First Posted: 2006-02-22
• Primary Completion: 2007-12
• Study Completion: 2008-04
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-26
• Last Update Posted: 2009-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bacteriuria five days after prostate biopsy

Secondary Outcome Measures

Name	Time	Method
- Clinically diagnosed infectious complications
- Other complications related to the procedure

Trial Locations

Locations (1)

Poitiers Hospital University; 🇫🇷 Poitiers, France