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临床试验/EUCTR2016-001427-30-FI
EUCTR2016-001427-30-FI进行中(未招募)1 期

Antibiotic prophylaxis before extracorporeal shock wave lithotripsy (APPEAL) - APPEA

niversity of Helsinki / CLUE Working Group0 个研究点开始时间: 2016年6月23日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients (aged 18 years or older) undergoing extracorporeal shock wave lithotripsy for urinary stone disease
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 300
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Exclusion criteria are:
  • Pre-shock wave lithotripsy (SWL) urine analysis positive for nitrites
  • Pre-SWL urine culture reveals >105 CFU/ml of bacteria (positive urine culture)
  • Taking antibiotics for urinary tract infection or other cause
  • Suspected struvite stone (based on previous stone analysis, or partial staghorn)
  • Presence of nephrostomy tube
  • Requiring cystoscopy and ureteral stent insertion on the day of SWL
  • Presence of Foley catheter or patient on regular clean intermittent catheterization
  • Presence of urinary diversion (ie: ileal conduit)
  • History of urosepsis prior to SWL
  • Known allergic reaction to trial antibiotic
  • Previous randomization in this trial

研究者

发起方
niversity of Helsinki / CLUE Working Group

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