Clinical trial NCT01803191: Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy
Official title: Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: Transrectal ultrasound-guided prostate biopsy
Bacteriuria
Antibiotic prophylaxis
Prostate-Specific antigen
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Santa Lucía
name: Hospital General Universitario Los Arcos del Mar Menor
First posted: 2013-03-04
Enrollment: 461
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bacteriuria
timeFrame: 28 days
Secondary outcomes:
measure: Urinary Tract Infection
timeFrame: 28 days
measure: Sepsis
timeFrame: 28 days
measure: Pathogens present in urine and antimicrobial resistance
timeFrame: 28 days
measure: Bacteremia
timeFrame: 28 days
measure: Hematuria
timeFrame: 28 days
measure: Hemospermia
timeFrame: 28 days
measure: Rectal bleeding
timeFrame: 28 days
measure: Urinary retention
timeFrame: 28 days
measure: Difficulty for miction
timeFrame: 28 days
measure: Genitourinary infections associated to fever (>38ºC)
timeFrame: 28 days
measure: Number of participants with adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucía
state: Murcia
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: San Javier
country: Spain
facility: Hospital General Universitario Los Arcos del Mar Menor
state: Murcia
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Pedro PL Lopez Cubillana, MD
role: PRINCIPAL_INVESTIGATOR
References: