Fosfomycin 3 g
DrugUnique oral dosis of fosfomycin 1 hour before biopsy
NCT Number: NCT01803191
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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Notify Me18 year–85 year
Male
Interventional
Phase 4
Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unique oral dosis of fosfomycin 1 hour before biopsy
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy
Time frame: 28 days
Positive urine culture(>10000 ufc/ml)
Time frame: 28 days
clinical symptoms (burning urination, urgent urination, urinary frequency)
Time frame: 28 days
Systemic inflammatory response syndrome secondary to urinary tract infection
Time frame: 28 days
Time frame: 28 days
Presence of bacteria in the blood (blood culture positive)
Time frame: 28 days
Blood in urine (Complication of transrectal ultrasound guided prostate)
Time frame: 28 days
Blood in the semen (Complication of transrectal ultrasound guided prostate)
Time frame: 28 days
Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)
Time frame: 28 days
Complication of transrectal ultrasound guided prostate
Time frame: 28 days
Complication of transrectal ultrasound guided prostate
Time frame: 28 days
Fever >38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache
Time frame: 28 days
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Other
Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy
Acronym: BIPROST
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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