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


Phase 3
18 Years
N/A
Not Enrolling
Male
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Bacteriuria five days after prostate biopsy

Principal Investigator

Irani Jacques, professor

Investigator Role:

Principal Investigator

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2005-005959-17

NCT ID:

NCT00294749

Start Date:

February 2006

Completion Date:

April 2008

Related Keywords:

  • Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.
  • Prostate,
  • Infection,
  • Biopsy,
  • Antibiotic,
  • Prophylaxis
  • Prostatic Neoplasms

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