Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy
- Conditions
- Urinary Tract Infections
- Interventions
- Registration Number
- NCT01803191
- Lead Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 461
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fosfomycin 3 g Fosfomycin 3 g Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy Ciprofloxacin 500 mg Ciprofloxacin 500 mg Unique oral dosis of ciprofloxacin 500 mg before biopsy
- Primary Outcome Measures
Name Time Method Bacteriuria 28 days Positive urine culture(\>10000 ufc/ml)
- Secondary Outcome Measures
Name Time Method Bacteremia 28 days Presence of bacteria in the blood (blood culture positive)
Urinary Tract Infection 28 days clinical symptoms (burning urination, urgent urination, urinary frequency)
Sepsis 28 days Systemic inflammatory response syndrome secondary to urinary tract infection
Pathogens present in urine and antimicrobial resistance 28 days Hematuria 28 days Blood in urine (Complication of transrectal ultrasound guided prostate)
Hemospermia 28 days Blood in the semen (Complication of transrectal ultrasound guided prostate)
Rectal bleeding 28 days Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)
Urinary retention 28 days Complication of transrectal ultrasound guided prostate
Difficulty for miction 28 days Complication of transrectal ultrasound guided prostate
Genitourinary infections associated to fever (>38ºC) 28 days Fever \>38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache
Number of participants with adverse events 28 days
Trial Locations
- Locations (3)
Hospital Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital General Universitario Santa Lucía
🇪🇸Cartagena, Murcia, Spain
Hospital General Universitario Los Arcos del Mar Menor
🇪🇸San Javier, Murcia, Spain