NCT01803191

Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose of ciprofloxacin 500 mg 1 hour before biopsy.

Detailed description

Transrectal ultrasound guided (TRUS) prostate biopsy is the procedure of choice for the diagnosis of prostate cancer. This technique is usually safe and well tolerated with a low incidence of serious complications. However, one of these complications, the bacterial infection can be complicated and cause urinary sepsis. The investigators have developed different regimens of antibiotic prophylaxis. Most of them include administering oral fluoroquinolones. In this area, approximately 40% of the strains of E. coli are resistant to ciprofloxacin (fluoroquinolone). Therefore, research is warranted alternative prophylactic approaches. Fosfomycin is an antibiotic ancient underused in recent decades that in recent years has been proposed as an alternative treatment for infections caused by multidrug-resistant microorganisms.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Fosfomycin 3 g	Unique oral dosis of fosfomycin 1 hour before biopsy
DRUG	Ciprofloxacin 500 mg	Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-01-25
• Completion: 2016-01-25
• First posted: 2013-03-04
• Last updated: 2017-12-13

Locations

3 sites across 1 country: Spain