Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

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

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00294749
• Other study ID #: 2005-005959-17
• Status: Terminated
• Phase: Phase 3
• First received: February 19, 2006
• Last updated: January 26, 2009
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: January 2009
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ciprofloxacine

Locations

Country	Name	City	State
France	Poitiers Hospital University	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriuria five days after prostate biopsy
Secondary	- Clinically diagnosed infectious complications
Secondary	- Other complications related to the procedure