Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00294749
Recruitment Status : Terminated
First Posted : February 22, 2006
Last Update Posted : January 27, 2009
Information provided by:
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

Condition or disease Intervention/treatment Phase
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion. Drug: Ciprofloxacine Phase 3

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
Study Start Date : February 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Biopsy

Primary Outcome Measures :
  1. Bacteriuria five days after prostate biopsy

Secondary Outcome Measures :
  1. - Clinically diagnosed infectious complications
  2. - Other complications related to the procedure

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00294749

Poitiers Hospital University
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
Principal Investigator: Irani Jacques, professor Identifier: NCT00294749     History of Changes
Other Study ID Numbers: 2005-005959-17
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by Poitiers University Hospital:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors