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Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00294749
First Posted: February 22, 2006
Last Update Posted: January 27, 2009
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.
Information provided by:
Poitiers University Hospital
  Purpose
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 Intervention Phase
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion. Drug: Ciprofloxacine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • Bacteriuria five days after prostate biopsy

Secondary Outcome Measures:
  • - Clinically diagnosed infectious complications
  • - Other complications related to the procedure

Estimated Enrollment: 300
Study Start Date: February 2006
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00294749


Locations
France
Poitiers Hospital University
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Principal Investigator: Irani Jacques, professor
  More Information

ClinicalTrials.gov Identifier: NCT00294749     History of Changes
Other Study ID Numbers: 2005-005959-17
First Submitted: February 19, 2006
First Posted: February 22, 2006
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by Poitiers University Hospital:
Prostate,
Infection,
Biopsy,
Antibiotic,
Prophylaxis

Additional relevant MeSH terms:
Anti-Bacterial Agents
Ciprofloxacin
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