Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-04-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Ciprofloxacine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No