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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001031-31 | EudraCT Number |
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| Name | Class |
|---|---|
| Hospital General Universitario Santa Lucía | OTHER |
| Hospital General Universitario Los Arcos del Mar Menor | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fosfomycin 3 g | Experimental | Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy |
|
| Ciprofloxacin 500 mg | Active Comparator | Unique oral dosis of ciprofloxacin 500 mg before biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosfomycin 3 g | Drug | Unique oral dosis of fosfomycin 1 hour before biopsy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteriuria | Positive urine culture(>10000 ufc/ml) | 28 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro PL Lopez Cubillana, MD | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Santa Lucía | Cartagena | Murcia | 30202 | Spain | ||
| Hospital Universitario Virgen de la Arrixaca |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005578 | Fosfomycin |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D024841 | Fluoroquinolones |
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| Ciprofloxacin 500 mg |
| Drug |
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy |
|
| 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 |
| El Palmar |
| Murcia |
| 30150 |
| Spain |
| Hospital General Universitario Los Arcos del Mar Menor | San Javier | Murcia | 30739 | Spain |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D042462 |
| 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |