Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

Study Overview
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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.

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

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Fosfomycin 3 g
* Drug: Ciprofloxacin 500 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fosfomycin 3 g<br>Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy | Drug: Fosfomycin 3 g<br>* Unique oral dosis of fosfomycin 1 hour before biopsy<br>|
| Active Comparator: Ciprofloxacin 500 mg<br>Unique oral dosis of ciprofloxacin 500 mg before biopsy | Drug: Ciprofloxacin 500 mg<br>* Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriuria | Positive urine culture(>10000 ufc/ml) | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Tract Infection | clinical symptoms (burning urination, urgent urination, urinary frequency) | 28 days | 
| Sepsis | Systemic inflammatory response syndrome secondary to urinary tract infection | 28 days | 
| Pathogens present in urine and antimicrobial resistance |  | 28 days | 
| Bacteremia | Presence of bacteria in the blood (blood culture positive) | 28 days | 
| Hematuria | Blood in urine (Complication of transrectal ultrasound guided prostate) | 28 days | 
| Hemospermia | Blood in the semen (Complication of transrectal ultrasound guided prostate) | 28 days | 
| Rectal bleeding | Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate) | 28 days | 
| Urinary retention | Complication of transrectal ultrasound guided prostate | 28 days | 
| Difficulty for miction | Complication of transrectal ultrasound guided prostate | 28 days | 
| Genitourinary infections associated to fever (>38ºC) | Fever >38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache | 28 days | 
| Number of participants with adverse events |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transrectal ultrasound-guided prostate biopsy, Bacteriuria, Antibiotic prophylaxis, Prostate-Specific antigen