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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor:
Collaborators:
Hospital General Universitario Santa Lucía
Hospital General Universitario Los Arcos del Mar Menor
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:
NCT01803191
First received: February 14, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infections
Drug: Fosfomycin 3 g
Drug: Ciprofloxacin 500 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy

Resource links provided by NLM:


Further study details as provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:

Primary Outcome Measures:
  • Bacteriuria [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Positive urine culture(>10000 ufc/ml)


Secondary Outcome Measures:
  • Urinary Tract Infection [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    clinical symptoms (burning urination, urgent urination, urinary frequency)

  • Sepsis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Systemic inflammatory response syndrome secondary to urinary tract infection

  • Pathogens present in urine and antimicrobial resistance [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Bacteremia [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Presence of bacteria in the blood (blood culture positive)

  • Hematuria [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Blood in urine (Complication of transrectal ultrasound guided prostate)

  • Hemospermia [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Blood in the semen (Complication of transrectal ultrasound guided prostate)

  • Rectal bleeding [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)

  • Urinary retention [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Complication of transrectal ultrasound guided prostate

  • Difficulty for miction [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Complication of transrectal ultrasound guided prostate

  • Genitourinary infections associated to fever (>38ºC) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Fever >38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache

  • Number of participants with adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 470
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803191

Contacts
Contact: Pedro PL López, MD 968369500 pedrolopezcubillana@gmail.com
Contact: Juan JM Moreno, MD 968128600 jmorenoav@gmail.com

Locations
Spain
Hospital General Universitario Santa Lucía Recruiting
Cartagena, Murcia, Spain, 30202
Contact: Juan Moreno Aviles, MD    968128600    jmorenoav@gmail.com   
Principal Investigator: Juan Moreno Avilés, MD         
Sub-Investigator: Carlos García Espona, MD         
Sub-Investigator: Jose M Cervell Ferrón, MD         
Sub-Investigator: Almudena Rodríguez Tardido, MD         
Sub-Investigator: Enrique Cao Avellaneda, MD         
Sub-Investigator: Eugenio Hita Rosino, MD         
Sub-Investigator: Francisco Jimenez Penick, MD         
Sub-Investigator: Juan M Soler Fernández, MD         
Sub-Investigator: Max Cachay Ayala, MD         
Hospital Universitario Virgen de la Arrixaca Recruiting
El Palmar, Murcia, Spain, 30150
Contact: Maria Muñoz Garcia    968 381290    maria.munoz@ffis.es   
Principal Investigator: Pedro Lopez Cubillana, MD         
Sub-Investigator: Pablo Martinez Pertusa, MD         
Sub-Investigator: Angel Guardiola Mas, Md         
Sub-Investigator: Antonio Prieto González, MD         
Sub-Investigator: Guillermo Gómez Gómez, MD         
Sub-Investigator: Gerardo Server Pastor, MD         
Sub-Investigator: Jose A García Hernández, MD         
Sub-Investigator: Jose A Nicolas Torralba, MD         
Sub-Investigator: Jose Félix Escudero Bregante, MD         
Sub-Investigator: Jesús I Tornero Ruiz, MD         
Sub-Investigator: Mariano Rigabert Montiel, MD         
Sub-Investigator: Pedro A López gonzález, MD         
Sub-Investigator: Jose C Ruiz Morcillo, MD         
Sub-Investigator: Cristobal Moreno alarcón, MD         
Sub-Investigator: Edgar Olarte Barragán, MD         
Sub-Investigator: Cindy P. Pinzón Navarrete, MD         
Sub-Investigator: Pablo Gutierrez Gutierrez, MD         
Sub-Investigator: Jose A Herrero Martinez, MD         
Sub-Investigator: Juan D Aviles Hernandez, MD         
Hospital General Universitario Los Arcos del Mar Menor Recruiting
San Javier, Murcia, Spain, 30739
Contact: Pablo Guzmán Martinez-Valls, MD    968565030    pabloguzmanmv@gmail.com   
Principal Investigator: Pablo Guzman Martínez Valls, MD         
Sub-Investigator: Alejandro Maluff Torres, MD         
Sub-Investigator: Beatriz Honrubia Vilchez, MD         
Sub-Investigator: Gloria Doñate Iñiguez, MD         
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital General Universitario Santa Lucía
Hospital General Universitario Los Arcos del Mar Menor
Investigators
Principal Investigator: Pedro PL Lopez Cubillana, MD Hospital Universitario Virgen de la Arrixaca
  More Information

No publications provided

Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier: NCT01803191     History of Changes
Other Study ID Numbers: BIPROST, 2012-001031-31
Study First Received: February 14, 2013
Last Updated: March 18, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Transrectal ultrasound-guided prostate biopsy
Bacteriuria
Antibiotic prophylaxis
Prostate-Specific antigen

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Ciprofloxacin
Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014