Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Poitiers University Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Bacteriuria five days after prostate biopsy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Bacteriuria five days after prostate biopsy
Secondary Outcomes
- - Clinically diagnosed infectious complications
- - Other complications related to the procedure