NCT01803191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2016

Completed
Last Updated

December 13, 2017

Status Verified

March 1, 2017

Enrollment Period

3.5 years

First QC Date

February 14, 2013

Last Update Submit

December 12, 2017

Conditions

Urinary Tract Infections

Keywords

Transrectal ultrasound-guided prostate biopsyBacteriuriaAntibiotic prophylaxisProstate-Specific antigen

Outcome Measures

Primary Outcomes (1)

  • Bacteriuria

    Positive urine culture(\>10000 ufc/ml)

    28 days

Secondary Outcomes (11)

  • Urinary Tract Infection

    28 days

  • Sepsis

    28 days

  • Pathogens present in urine and antimicrobial resistance

    28 days

  • Bacteremia

    28 days

  • Hematuria

    28 days

  • +6 more secondary outcomes

Study Arms (2)

Fosfomycin 3 g

EXPERIMENTAL

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

Drug: Fosfomycin 3 g

Ciprofloxacin 500 mg

ACTIVE COMPARATOR

Unique oral dosis of ciprofloxacin 500 mg before biopsy

Drug: Ciprofloxacin 500 mg

Interventions

Fosfomycin 3 gDRUG

Unique oral dosis of fosfomycin 1 hour before biopsy

Fosfomycin 3 g
Ciprofloxacin 500 mgDRUG

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

Ciprofloxacin 500 mg

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30150, Spain

Location

Hospital General Universitario Los Arcos del Mar Menor

San Javier, Murcia, 30739, Spain

Location

MeSH Terms

Conditions

Urinary Tract InfectionsBacteriuria

Interventions

FosfomycinCiprofloxacin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pedro PL Lopez Cubillana, MD

    Hospital Universitario Virgen de la Arrixaca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

March 4, 2013

Study Start

August 1, 2012

Primary Completion

January 25, 2016

Study Completion

January 25, 2016

Last Updated

December 13, 2017

Record last verified: 2017-03

Locations

ES(3)