Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Bacteriuria five days after prostate biopsy
研究概览
简要总结
The purpose of this study is to determine whether long antibiotic prophylactic is more effective than a short traitement in infective complications for prostate biopsy
详细描述
Prophylactic antibiotic is used to minimize the infective complications risk following transrectal biopsy of the prostate.
The majority of works points to the need of antibiotic prophylaxis previously to transrectal prostate biopsy. However, there is a lot of controversy and diversity of therapeutic schemes in the literature concerning the ideal drug to be used and the time employed for infectious prophylaxis.
The objective of this randomised study was to assess 2 different schemes of antimicrobial prophylaxis, aiming to determine the difference in infective complications with a single dose of ciprofloxacin 2 hours before the procedure vs. ciprofloxacin for 3 days
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •abnormal digital rectal examination
- •abnormal PSA values
- •To be excluded those patients with:
- •ciprofloxacine contraindication
- •indwelling urethral catheter,
- •positive urine culture,
- •presence of cardiac valve prosthesis,
- •uncontrolled diabetes mellitus,
- •use of antimicrobials in the 7 days prior to biopsy.
- •Urinary endoscopic procedure in the 7 days prior to biopsy
- •coagulation defect
- •Renal insufficiency
- •Hepatic insufficiency
排除标准
- 未提供
结局指标
主要结局
Bacteriuria five days after prostate biopsy
次要结局
- - Clinically diagnosed infectious complications
- - Other complications related to the procedure