Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

Urinary Tract Infections Clinical Trial

— BIPROST  

Official title:

Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803191
• Other study ID #: BIPROST
• Secondary ID: 2012-001031-31
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2013
• Last updated: December 12, 2017
• Start date: August 2012
• Est. completion date: January 25, 2016

Study information

• Verified date: March 2017
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: January 25, 2016
• Est. primary completion date: January 25, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Drug:
• Fosfomycin 3 g
Unique oral dosis of fosfomycin 1 hour before biopsy
• Ciprofloxacin 500 mg
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy

Locations

Country	Name	City	State
Spain	Hospital General Universitario Santa Lucía	Cartagena	Murcia
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital General Universitario Los Arcos del Mar Menor	San Javier	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	Hospital General Universitario Los Arcos del Mar Menor, Hospital General Universitario Santa Lucía

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriuria	Positive urine culture(>10000 ufc/ml)	28 days
Secondary	Urinary Tract Infection	clinical symptoms (burning urination, urgent urination, urinary frequency)	28 days
Secondary	Sepsis	Systemic inflammatory response syndrome secondary to urinary tract infection	28 days
Secondary	Pathogens present in urine and antimicrobial resistance		28 days
Secondary	Bacteremia	Presence of bacteria in the blood (blood culture positive)	28 days
Secondary	Hematuria	Blood in urine (Complication of transrectal ultrasound guided prostate)	28 days
Secondary	Hemospermia	Blood in the semen (Complication of transrectal ultrasound guided prostate)	28 days
Secondary	Rectal bleeding	Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)	28 days
Secondary	Urinary retention	Complication of transrectal ultrasound guided prostate	28 days
Secondary	Difficulty for miction	Complication of transrectal ultrasound guided prostate	28 days
Secondary	Genitourinary infections associated to fever (>38ºC)	Fever >38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache	28 days
Secondary	Number of participants with adverse events		28 days