Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study

Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

Sponsors

Lead sponsor: Poitiers University Hospital

Source 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

Overall Status Terminated
Start Date February 2006
Completion Date April 2008
Primary Completion Date December 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Bacteriuria five days after prostate biopsy
Secondary Outcome
Measure Time Frame
- Clinically diagnosed infectious complications
- Other complications related to the procedure
Enrollment 300
Condition
Intervention

Intervention type: Drug

Intervention name: Ciprofloxacine

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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role
Irani Jacques, professor Principal Investigator
Location
facility Poitiers Hospital University
Location Countries

France

Verification Date

January 2009

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov