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

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Fosfomycin 3 g
Ciprofloxacin 500 mg
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring Transrectal ultrasound-guided prostate biopsy, Bacteriuria, Antibiotic prophylaxis, Prostate-Specific antigen

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Hospital General Universitario Santa Lucía
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital General Universitario Los Arcos del Mar Menor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fosfomycin 3 g

Ciprofloxacin 500 mg

Arm Description

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

Unique oral dosis of ciprofloxacin 500 mg before biopsy

Outcomes

Primary Outcome Measures

Bacteriuria
Positive urine culture(>10000 ufc/ml)

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2013
Last Updated
December 12, 2017
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
Hospital General Universitario Santa Lucía, Hospital General Universitario Los Arcos del Mar Menor
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1. Study Identification

Unique Protocol Identification Number
NCT01803191
Brief Title
Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy
Acronym
BIPROST
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
January 25, 2016 (Actual)
Study Completion Date
January 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
Hospital General Universitario Santa Lucía, Hospital General Universitario Los Arcos del Mar Menor

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Transrectal ultrasound-guided prostate biopsy, Bacteriuria, Antibiotic prophylaxis, Prostate-Specific antigen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
461 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fosfomycin 3 g
Arm Type
Experimental
Arm Description
Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy
Arm Title
Ciprofloxacin 500 mg
Arm Type
Active Comparator
Arm Description
Unique oral dosis of ciprofloxacin 500 mg before biopsy
Intervention Type
Drug
Intervention Name(s)
Fosfomycin 3 g
Intervention Description
Unique oral dosis of fosfomycin 1 hour before biopsy
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin 500 mg
Intervention Description
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy
Primary Outcome Measure Information:
Title
Bacteriuria
Description
Positive urine culture(>10000 ufc/ml)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Urinary Tract Infection
Description
clinical symptoms (burning urination, urgent urination, urinary frequency)
Time Frame
28 days
Title
Sepsis
Description
Systemic inflammatory response syndrome secondary to urinary tract infection
Time Frame
28 days
Title
Pathogens present in urine and antimicrobial resistance
Time Frame
28 days
Title
Bacteremia
Description
Presence of bacteria in the blood (blood culture positive)
Time Frame
28 days
Title
Hematuria
Description
Blood in urine (Complication of transrectal ultrasound guided prostate)
Time Frame
28 days
Title
Hemospermia
Description
Blood in the semen (Complication of transrectal ultrasound guided prostate)
Time Frame
28 days
Title
Rectal bleeding
Description
Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)
Time Frame
28 days
Title
Urinary retention
Description
Complication of transrectal ultrasound guided prostate
Time Frame
28 days
Title
Difficulty for miction
Description
Complication of transrectal ultrasound guided prostate
Time Frame
28 days
Title
Genitourinary infections associated to fever (>38ºC)
Description
Fever >38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache
Time Frame
28 days
Title
Number of participants with adverse events
Time Frame
28 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro PL Lopez Cubillana, MD
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario Santa Lucía
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30202
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30150
Country
Spain
Facility Name
Hospital General Universitario Los Arcos del Mar Menor
City
San Javier
State/Province
Murcia
ZIP/Postal Code
30739
Country
Spain

12. IPD Sharing Statement

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Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

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