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临床试验/EUCTR2008-007669-21-BE
EUCTR2008-007669-21-BE进行中(未招募)1 期

Effectiveness of prophylactic antibiotic intervention (fosfomycin trometamol) to prevent urinary tract infections due to urodynamic studies in women with urine incontinence or prolapsed: a randomized controlled trial - USA (Urodynamic Studies Antibioprophylaxy)

CHU of Liège0 个研究点目标入组 350 人开始时间: 2009年11月30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
入组人数
350

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
Female

入选标准

  • 1. women aged 18- 80 years
  • 2. attending the urodynamic outpatient clinic of the Department of Obstetrics and Gynecology at CHR La Citadelle, Liège for urodynamic investigations
  • 3. without symptoms of urogenital infection at the time of UDS attested by a positive result at stick test of urinary sample
  • 4. intellectually and/or linguistically able to understand the study
  • 5. not suffering from mental disabilities (except depression and anxiety)
  • 6. resident within the surroundings of Liege.
  • 7. willing to give their written consent
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • History of recurrent urinary tract infection
  • Impaired renal function
  • Intermittent self-catheterization
  • Presence of persistent urinary infection *
  • Breastfeeding
  • Short term child-bearing potential**
  • Allergy to antibiotics
  • Antibiotics in the previous 7 days
  • * urinary infection - indicated by a positive stick test for nitrites and/or pyuria - which does not respond adequately to fosfomycin trometamol administration on the long term (1 month)
  • **sexually active women who apply an unreliable method of birth control or who have an acute wish to become pregnant

研究者

发起方
CHU of Liège

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