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Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

NCT ID: NCT01803191

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-01-25

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Keywords

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Transrectal ultrasound-guided prostate biopsy Bacteriuria Antibiotic prophylaxis Prostate-Specific antigen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fosfomycin 3 g

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

Group Type EXPERIMENTAL

Fosfomycin 3 g

Intervention Type DRUG

Unique oral dosis of fosfomycin 1 hour before biopsy

Ciprofloxacin 500 mg

Unique oral dosis of ciprofloxacin 500 mg before biopsy

Group Type ACTIVE_COMPARATOR

Ciprofloxacin 500 mg

Intervention Type DRUG

Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy

Interventions

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Fosfomycin 3 g

Unique oral dosis of fosfomycin 1 hour before biopsy

Intervention Type DRUG

Ciprofloxacin 500 mg

Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Santa Lucía

OTHER

Sponsor Role collaborator

Hospital General Universitario Los Arcos del Mar Menor

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro PL Lopez Cubillana, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Arrixaca

Locations

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Hospital General Universitario Santa Lucía

Cartagena, Murcia, Spain

Site Status

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status

Hospital General Universitario Los Arcos del Mar Menor

San Javier, Murcia, Spain

Site Status

Countries

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Spain

Other Identifiers

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2012-001031-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIPROST

Identifier Type: -

Identifier Source: org_study_id