Status:
COMPLETED
Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
Hospital General Universitario Santa Lucía
Hospital General Universitario Los Arcos del Mar Menor
Conditions:
Urinary Tract Infections
Eligibility:
MALE
18-85 years
Phase:
PHASE4
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 hou...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2016
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT01803191
Start Date
August 1 2012
End Date
January 25 2016
Last Update
December 13 2017
Active Locations (3)
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1
Hospital General Universitario Santa Lucía
Cartagena, Murcia, Spain, 30202
2
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30150
3
Hospital General Universitario Los Arcos del Mar Menor
San Javier, Murcia, Spain, 30739