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
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