Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy (BIPROST)

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Ciprofloxacin 500 mg; Drug: Fosfomycin 3 g

Study type: Interventional

Funder types: Other

Identifiers

NCT01803191

BIPROST

2012-001031-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 461 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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461 participants in 2 patient groups

Fosfomycin 3 g

Experimental group

Description:

Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy

Treatment:

Drug: Fosfomycin 3 g

Ciprofloxacin 500 mg

Active Comparator group

Description:

Unique oral dosis of ciprofloxacin 500 mg before biopsy

Treatment:

Drug: Ciprofloxacin 500 mg