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Completed

NCT Number: NCT01803191

Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior 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.

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Key information

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fosfomycin 3 g

Drug

Unique oral dosis of fosfomycin 1 hour before biopsy

Ciprofloxacin 500 mg

Drug

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

Primary outcomes

  1. Bacteriuria

    Time frame: 28 days

    Positive urine culture(>10000 ufc/ml)

Secondary outcomes

  1. Urinary Tract Infection

    Time frame: 28 days

    clinical symptoms (burning urination, urgent urination, urinary frequency)

  2. Sepsis

    Time frame: 28 days

    Systemic inflammatory response syndrome secondary to urinary tract infection

  3. Pathogens present in urine and antimicrobial resistance

    Time frame: 28 days

  4. Bacteremia

    Time frame: 28 days

    Presence of bacteria in the blood (blood culture positive)

  5. Hematuria

    Time frame: 28 days

    Blood in urine (Complication of transrectal ultrasound guided prostate)

  6. Hemospermia

    Time frame: 28 days

    Blood in the semen (Complication of transrectal ultrasound guided prostate)

  7. Rectal bleeding

    Time frame: 28 days

    Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)

  8. Urinary retention

    Time frame: 28 days

    Complication of transrectal ultrasound guided prostate

  9. Difficulty for miction

    Time frame: 28 days

    Complication of transrectal ultrasound guided prostate

  10. Genitourinary infections associated to fever (>38ºC)

    Time frame: 28 days

    Fever >38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache

  11. Number of participants with adverse events

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Hospital General Universitario Los Arcos del Mar Menor
  • Hospital General Universitario Santa Lucía

Registry information

Official study title

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

Acronym: BIPROST

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2013
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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