Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

Poitiers University Hospital

Status and phase: Terminated; Phase 3

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

Treatments: Drug: Ciprofloxacine

Study type: Interventional

Funder types: Other

Identifiers

NCT00294749

2005-005959-17

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)