This trial has been completed.

Condition urinary tract infections
Treatments fosfomycin 3 g, ciprofloxacin 500 mg
Phase phase 4
Sponsor Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborator Hospital General Universitario Santa Lucía
Start date August 2012
End date January 2016
Trial size 461 participants
Trial identifier NCT01803191, 2012-001031-31, BIPROST


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose prevention
Masking no masking
Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy
fosfomycin 3 g
Unique oral dosis of fosfomycin 1 hour before biopsy
(Active Comparator)
Unique oral dosis of ciprofloxacin 500 mg before biopsy
ciprofloxacin 500 mg
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy

Primary Outcomes

time frame: 28 days

Secondary Outcomes

Urinary Tract Infection
time frame: 28 days
time frame: 28 days
Pathogens present in urine and antimicrobial resistance
time frame: 28 days
time frame: 28 days
time frame: 28 days
time frame: 28 days
Rectal bleeding
time frame: 28 days
Urinary retention
time frame: 28 days
Difficulty for miction
time frame: 28 days
Genitourinary infections associated to fever (>38ºC)
time frame: 28 days
Number of participants with adverse events
time frame: 28 days

Eligibility Criteria

Male participants from 18 years up to 85 years old.

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

Additional Information

Official title Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy
Principal investigator Pedro PL Lopez Cubillana, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia.