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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
461
Unique oral dosis of fosfomycin 1 hour before biopsy
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy
Hospital General Universitario Santa Lucía
Cartagena, Murcia, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital General Universitario Los Arcos del Mar Menor
San Javier, Murcia, Spain
Bacteriuria
Positive urine culture(\>10000 ufc/ml)
Time frame: 28 days
Urinary Tract Infection
clinical symptoms (burning urination, urgent urination, urinary frequency)
Time frame: 28 days
Sepsis
Systemic inflammatory response syndrome secondary to urinary tract infection
Time frame: 28 days
Pathogens present in urine and antimicrobial resistance
Time frame: 28 days
Bacteremia
Presence of bacteria in the blood (blood culture positive)
Time frame: 28 days
Hematuria
Blood in urine (Complication of transrectal ultrasound guided prostate)
Time frame: 28 days
Hemospermia
Blood in the semen (Complication of transrectal ultrasound guided prostate)
Time frame: 28 days
Rectal bleeding
Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)
Time frame: 28 days
Urinary retention
Complication of transrectal ultrasound guided prostate
Time frame: 28 days
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Difficulty for miction
Complication of transrectal ultrasound guided prostate
Time frame: 28 days
Genitourinary infections associated to fever (>38ºC)
Fever \>38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache
Time frame: 28 days
Number of participants with adverse events
Time frame: 28 days