EUCTR2018-001448-78-ES进行中（未招募）1 期
Single-site, open, randomized clinical trial to assess the non-inferiority ofCysticlean® versus Fosfomicina in the treatment of cystitis in women inSpain.
Vita Green Europa S.A.0 个研究点目标入组 128 人开始时间: 2018年10月25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
- 128
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 between 18 and 64 years.
- •2. With at least of two of the following signs / symptoms of cystitis: Dysuria, Stinging, Hematuria, Frequent, Urinary urgency
- •3. Cystitis caused by Escherichia coli
- •4. Written informed consent to participate in this clinical trial.
- •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 128
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Malaise
- •2. Currently receiving or has received antibiotics for any reason in the last month before entering the study
- •3. Active treatment with warfarin
- •4. Allergy to cranberry or any component of Cysticlean® or Fosfomycin
- •5. History of repeated episodes of acute pyelonephritis during the last year
- •6. Chills, malaise, fever or temperature higher than 37°C
- •7. Known morphological abnormalities of the urinary tract
- •8. Patients with known coagulation disorder
- •9. Women no to take highly effective contraceptive
- •10. Immunocompromised patients
- •11. Patients with urinary tract infection that is not caused by Escherichia coli
- •12. Patients with advanced cancer or with treatment
- •13. Patients with severe renal impairment
- •14.Patients undergoing hemodialysis
- •15. Patients who are allergic to acetylsalicylic acid
- •16. Patients taking metocloparamida
- •17. Participation in another interventional clinical study that could interfere with the results of this trial
- •18. In the investigator's opinion, is unable to meet the requirements of the study
研究者
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