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Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

This study has been terminated.
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00294749
First received: February 19, 2006
Last updated: January 26, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294749

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

No publications provided

ClinicalTrials.gov Identifier: NCT00294749     History of Changes
Other Study ID Numbers: 2005-005959-17
Study First Received: February 19, 2006
Last Updated: January 26, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013