EUCTR2018-000616-25-NL进行中（未招募）1 期
Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection
未提供0 个研究点目标入组 15 人开始时间: 2019年1月21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）
- 入组人数
- 15
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
入选标准
- •?Adults aged =18 years
- •?Treatment of UTI with oral fosfomycin 3 gram every 3rd day for 14 days or longer as indicated by attending physician
- •?Ability to communicate well with the investigator in the Dutch language
- •?Written informed 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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Renal insufficiency defined as an estimated GFR <30 ml/minute calculated by MDRD method
- •?Proven allergy for fosfomycin
- •?Pregnancy or breastfeeding
- •?Active malignancy
- •?Loss or donation of =500 mL of blood within 90 days prior to screening
- •?Participation in an investigational drug study within 90 days prior to Day 1 or more than 4 times a year
- •?Any known factor, condition, or disease that might interfere in the opinion of the PI with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- •?Usage of metoclopramide
研究者
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