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临床试验/NCT00480376
NCT00480376Unknown4 期

Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

HaEmek Medical Center, Israel2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2007年6月最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
160
试验地点
2
主要终点
no infection

研究概览

简要总结

Prostate biopsy is usually conducted transrectal, ultrasonography guided. Since the area is not sterile, infection can be induced during the procedure.

Prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections. Quinolones are considered preferred treatment but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

详细描述

Prostate biopsy is usually conducted as an ambulatory transrectal needle aspiration, ultrasonography guided. The area is not sterile, with high concentration of gram-negative and anaerobic pathogens, infection can be induced during the procedure to the urinary tract, and even cause bacteremia.

Prior studies concluded that prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections and hence it is accepted to give prophylaxis antibiotics which will cover especially gram-negative bacteria. Other studies show decrease in infections percent in patients that received prophylaxis opposed to those who did not, from 5-30% to less than 1%. Yet, there was no significant difference between those who received one dose and those who were treated for 3-5 days. Quinolones are considered preferred treatment since they can be given orally, but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

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
21 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients going under transrectal biopsy of prostate with sterile urine culture.

排除标准

  • Urine culture not sterile

结局指标

主要结局

no infection

时间窗: 48 hours

次要结局

  • no infection(7 days)

研究者

申办方类型
Other

研究点 (2)

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