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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Fosfomycin 3 g; Drug: Ciprofloxacin 500 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 461
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Hospital General Universitario Santa Lucía
    • El Palmar, Murcia, Spain, 30150
      • Hospital Universitario Virgen de la Arrixaca
    • San Javier, Murcia, Spain, 30739
      • Hospital General Universitario Los Arcos del Mar Menor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fosfomycin 3 g; Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy	Drug: Fosfomycin 3 g; Unique oral dosis of fosfomycin 1 hour before biopsy
Active Comparator: Ciprofloxacin 500 mg; Unique oral dosis of ciprofloxacin 500 mg before biopsy	Drug: Ciprofloxacin 500 mg; Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteriuria	Positive urine culture(>10000 ufc/ml)	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Collaborators: Hospital General Universitario Santa Lucia; Hospital General Universitario Los Arcos del Mar Menor
• Investigators: Principal Investigator: Pedro PL Lopez Cubillana, MD, Hospital Universitario Virgen de la Arrixaca

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): January 25, 2016
• Study Completion (Actual): January 25, 2016

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 4, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Bacteriuria; Antibiotic prophylaxis; Transrectal ultrasound-guided prostate biopsy; Prostate-Specific antigen
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin; Fosfomycin
• Other Study ID Numbers: BIPROST; 2012-001031-31 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No