Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 461
- 试验地点
- 3
- 主要终点
- Bacteriuria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fosfomycin 3 g
Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy
干预措施: Fosfomycin 3 g (Drug)
Ciprofloxacin 500 mg
Unique oral dosis of ciprofloxacin 500 mg before biopsy
干预措施: Ciprofloxacin 500 mg (Drug)
结局指标
主要结局
Bacteriuria
时间窗: 28 days
Positive urine culture(\>10000 ufc/ml)
次要结局
- Bacteremia(28 days)
- Urinary Tract Infection(28 days)
- Sepsis(28 days)
- Pathogens present in urine and antimicrobial resistance(28 days)
- Hematuria(28 days)
- Hemospermia(28 days)
- Rectal bleeding(28 days)
- Urinary retention(28 days)
- Difficulty for miction(28 days)
- Genitourinary infections associated to fever (>38ºC)(28 days)
- Number of participants with adverse events(28 days)