EUCTR2013-004961-14-SE进行中（未招募）1 期
Pilot study to investigate the mode of action (MoA) of Uro-Vaxom® on a molecular level in pre-menopausal women suffering from recurrent urinary tract infections (rUTI) - OM-89 Modes of action study in women with recurrent UTI
Kliniken Kärnan Urology Centre0 个研究点目标入组 10 人开始时间: 2014年4月29日最近更新:
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
- 10
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
- •Otherwise healthy pre-menopausal females who are naïve to OM-89 prophylaxis (>18 years old) suffering from recurrent non-febrile lower UTI (=3 UTIs in previous year. UTI episodes should be documented by repeated cultures and at least 2 clinical symptoms and there should be a minimum interval of 2 weeks between each infection episode).
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Diabetes mellitus type 1
- •- Poorly controlled diabetes mellitus type 2
- •- Treatment of malignant diseases in the past two years
- •- Corticosteroid treatment
- •- Auto-immune disorders
- •- Immune deficiency or immune compromised conditions
- •- Multiple sclerosis
- •- Women: pregnant or intending to be pregnant and not using acceptable contraceptives, menopausal status
- •- Previous OM-89 treatment
研究者
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