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临床试验/NCT02423759
NCT02423759已完成4 期

A Randomized Controlled Trial Comparing Rectal Swab Culture Based Chemoprophylaxis Versus Combined Single-Shot Gentamycin and Ciprofloxacin Versus Ciprofloxacin Alone for Peri-procedure Chemoprophylaxis During Transrectal Prostate Biopsy.

Mansoura University1 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
510
试验地点
1
主要终点
occurrence of post procedure infectious complications

研究概览

简要总结

The aim of the study is to evaluate whether changing antibiotic prophylaxis from fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted antibiotic prophylaxis according to rectal swab culture would influence infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.

详细描述

Introduction Transrectal ultrasound (TRUS) guided prostate biopsy is the standard procedure for the histological diagnosis and grading of prostate cancer that consequently help in providing the appropriate line of treatment. Risks of infectious complications post TRUS-guided biopsy have increased in the last years.

In their study, a total of 5798 TRUS-guided biopsies performed between 2002 and 2011. Increased incidence of infectious complications is noted from 0.52 infections per 100 biopsies between 2002 and 2009 to 2.15 infections per 100 biopsies between 2010 and 2011 (P< 0.001). The commonest organism found to be responsible for these infectious complications is Escherichia coli (E. Coli).

The American Urological Association best practice policy statement recommends antibiotic prophylaxis prior to transrectal prostate biopsy. The current practice is to give patients a dose of an oral fluoroquinolone (FQ) 30 to 60 minutes before biopsy and to be continued for 2 to 3 days after.

Recent studies show that 2% of patients will develop febrile urinary tract infection or even urosepsis and require hospitalization for intravenous antibiotics . There is considerable concern regarding the rising incidence of community-acquired antibiotic-resistant organisms.

It is proposed that resistant organisms are introduced into the bladder and the blood stream from the rectum during the procedure that's why patients already colonized with these resistant organisms may be at higher risk. Thereby, some authors suggest a targeted rectal swab culture before (TRUS)-guided biopsy then giving the appropriate antibiotic prophylaxis aiming at reducing post biopsy infection rates while minimizing unnecessary broad-spectrum antibiotic use.

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
Single (Participant)

入排标准

性别
Male
接受健康志愿者

入选标准

  • Prothrombin concentration > 70%
  • Platelet count > 100.000/cm

排除标准

  • Acute prostatitis (positive symptoms and signs)
  • Patients with compromised renal function (serum creatinine >1.6 mg/dl)
  • Uncontrolled DM
  • Patients on immunosuppressive therapy
  • Active steroid intake
  • Untreated bleeding diathesis

研究组 & 干预措施

ciprofloxacin

Active Comparator

standard chemoprophylaxis [500mg ciprofloxacin twice daily for 3 days]

干预措施: ciprofloxacin (Drug)

ciprofloxacin and gentamycine

Experimental

Augmented Chemoprophylaxis [standard chemoprophylaxis plus 160mg]

干预措施: ciprofloxacin and gentamycine (Drug)

culture based chemoprophylaxis

Experimental

Patients will receive antibiotic according to rectal swab culture at time of biopsy and then after for 3 days.

干预措施: culture based chemoprophylaxis (Drug)

结局指标

主要结局

occurrence of post procedure infectious complications

时间窗: 2 weeks

occurrence of post procedure infectious complications (e.g urosepsis and local genital or prostate infectious complications). Sepsis is identified as occurrence of two or more of SIRS criteria.

次要结局

  • flouroquinolones resistance in rectal carriage(2 weeks)
  • post procedure non-infectious complications(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Elshal

Dr

Mansoura University

研究点 (1)

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