EUCTR2016-004842-27-DE进行中（未招募）1 期
Clinical Trial to investigate the efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in the prophylaxis of catheter associated urinary tract infections - CAUTI
Repha GmbH0 个研究点目标入组 100 人开始时间: 2017年3月16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
- 100
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
- All
入选标准
- •Patients of both sexes = 18 years of age who want to participate in a prophylaxis study after treatment of a catheter-associated urinary tract infection (CAUTI) and who are currently not relevant for Treatment:
- •Subgroup I - Paraplegic patients
- •o Urine culture < 10^5 cfu/mL and LEU < 100/mm^3 or
- •o Urine culture < 10^5 cfu /mL or
- •o LEU < 100/mm^3
- •Subgroup II - Non-Paraplegic Patients
- •o urine culture < 10^5 cfu/mL and no clinical symptoms or
- •o no clinical symptoms or
- •o urine culture < 10^5 cfu/mL
- •symptoms are i. a. dysuria, flank pain, fever, signs of an autonomous dysreflexia
- •Patients having signed 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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Progression of infection proximal of urinary bladder or spreading of pathogens (urosepsis)
- •- Signs of restricted renal function
- •- Known Glomerulonephritis / interstitial nephritis or proteinuria
- •- Acute infections besides infections of the lower urinary tract during Screening Phase (visit 1 to visit 2)
- •- Acute gastric ulcer or acute ulcer of duodenum
- •- Abnormal laboratory results (clinically significant, i. e. more than three-times different compared to upper and lower laboratory standard-thresholds, except inflammatory parameters CRP (blood), leukocytes (urine), erythrocytes (urine)
- •- patients for whom permanent antibiotic therapy is required (permanent means > 1 week)
- •- patients with catheter systems, in which the catheter itself is not in contact with any outer-body region (e. g. double J ureteral stent)
- •- Patients with risk factors for a more severe Progression: inadequately controlled Diabetes mellitus, diseases of the fascia, polycistic nephropathy
- •- Abnormal INR value in patients undergoing anticoagulation therapy or anticoagulation prophylaxis with vitamin K antagonists (clinically significant, i.e. depending on the indication or signinficant at the investigator´s discretion)
- •- Known hypersensitivity to nasturtium, horseradish root or any
- •excipient of the study medication
- •- immune supressed patients (patients with organ transplantation within the previous 3 years, patients with HIV, etc.)
- •- Patients with malignant diseases of the urinary tract (kidney, Ureter, bladder, genital) within the previous 5 years
- •- Patients with a medical condition or a situation which, in the opinion of the investigator, poses a significant risk to the patient or which could impair or considerably influence the results of the Trial
- •- Pregnant or breast-feeding women or women planning to become pregnant; women capable of bearing children and not applying a highly effective contraception (Pearl Index <1)
- •- Simultaneous participation in another trial or participation in a clinical trial within the last 30 days before inclusion into this Trial
- •- Known abuse of medicinal products, alcohol or other drugs
- •- Serious diseases of the Psyche
- •- Persons which are institutionalised by regulatory or judicial decree
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