Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

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

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

Study Overview

• Status: Terminated
• Conditions: Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.
• Intervention / Treatment: Drug: Ciprofloxacine

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Poitiers Hospital University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bacteriuria five days after prostate biopsy

Secondary Outcome Measures

Outcome Measure
- Clinically diagnosed infectious complications
- Other complications related to the procedure

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Irani Jacques, professor

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 19, 2006
• First Submitted That Met QC Criteria: February 19, 2006
• First Posted (Estimate): February 22, 2006

Study Record Updates

• Last Update Posted (Estimate): January 27, 2009
• Last Update Submitted That Met QC Criteria: January 26, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Prophylaxis; Prostate,; Infection,; Biopsy,; Antibiotic,
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 2005-005959-17