Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294749

Enrollment

300

Registered

2006-02-22

Start date

2006-02-28

Completion date

2008-04-30

Last updated

2009-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Prostate,, Infection,, Biopsy,, Antibiotic,, Prophylaxis

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

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

Interventions

DRUGCiprofloxacine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Bacteriuria five days after prostate biopsy	—

Secondary

Measure	Time frame
- Clinically diagnosed infectious complications	—
- Other complications related to the procedure	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026