Urinary Tract Infections
Conditions
Keywords
Transrectal ultrasound-guided prostate biopsy, Bacteriuria, Antibiotic prophylaxis, Prostate-Specific antigen
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.
Interventions
DRUGFosfomycin 3 g
Unique oral dosis of fosfomycin 1 hour before biopsy
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy
Sponsors
Hospital General Universitario Santa Lucía
Hospital General Universitario Los Arcos del Mar Menor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteriuria | 28 days | Positive urine culture(\>10000 ufc/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) |
| Difficulty for miction | 28 days | Complication of transrectal ultrasound guided prostate |
| 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 | — |
| Bacteremia | 28 days | Presence of bacteria in the blood (blood culture positive) |
| Urinary retention | 28 days | Complication of transrectal ultrasound guided prostate |
Countries
Spain
Outcome results
None listed