Trial | NCT01803191  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    461
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.
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.
Study Started
Aug 31
2012
Primary Completion
Jan 25
2016
Study Completion
Jan 25
2016
Last Update
Dec 13
2017

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

Fosfomycin 3 g Experimental

Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy

Ciprofloxacin 500 mg Active Comparator

Unique oral dosis of ciprofloxacin 500 mg before biopsy

Criteria 

Inclusion Criteria:

Age > 18 years
Patients with prostate-specific antigen (PSA) values >4 ng/ml or presenting either abnormality in rectal examination
Patients who accept to participate in the study signing the consent informed form

Exclusion Criteria:

Allergy to anyone of the study drug
Intolerance to anyone of the study drug
Urinary infection with positive uroculture
Clinical finds suggesting infections
Antimicrobial treatment during the las 4 weeks
Patients with vesicle catheter
Patients in dialysis
Patients in hemodialysis
No Results Posted