EUCTR2010-020882-25-DE进行中（未招募）不适用
Prospective Multicentre Randomized Double-Blind Placebo-Controlled Parallel Group Study on the Efficacy and Tolerability of StroVac® in Patients With Recurrent Symptomatic Bacterial Urinary Tract Infections - RUDIS -Study
Strathmann GmbH & Co. KG0 个研究点开始时间: 2011年11月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Males and females aged 18 to 80 years
- •2.Patients with a history of at least one year of recurrent uncomplicated symptomatic bacterial urinary tract infections
- •3.Patients with at least five confirmed episodes of uncomplicated symp-tomatic bacterial urinary tract infections during a period of twelve months prior to study inclusion
- •4.Patients who have given their signed declaration of consent and data protection declaration after having been informed about the nature, relevance and the scope of the study and about the expected desired and undesired effects of the investigative medicinal product
- •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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Complicated urinary tract infections or other diseases of the urinary tract such as non-bacterial cystitis or diseases/anomalies associated with an obstruction such as bladder or kidney stones, strictures of ureter or benign prostatic hyperplasia with urinary retention (Confirmation by ultrasound of kidney and bladder and determination of residual amount of > 50 ml urine).
- •2.Patients suffering from overactive bladder (> 8 micturitions per day and clinically not significant urinanalysis)
- •3.Contraindications for the application of the investigational medicinal product
- •-Acute infectious diseases, excluding urogenital diseases
- •-Active tuberculosis
- •-Severe diseases of the hematopoietic system
- •-Severe cardiac or renal disease
- •-Diseases of the immune system
- •-Hypersensitivity towards StroVac®
- •4.Malfunction of immunity as a result of diseases like diabetes mellitus with instable metabolic status or presence of manifest late diabetic complications or liver insufficiency
- •5.Any malignancy less than 5 years ago (except basal cell carcinoma)
- •6.Any radiation therapy of the abdomen (without time limitation) or radiation therapy of another body part within the last 5 years prior to start of study or planned during study
- •7.Intake of not permitted previous therapy
- •8.Planned intake or application of concomitant therapy which is not per-mitted during the study
- •9.Hospitalization within the last 12 months prior to study start or planned during the study
- •10.Inhabitants of nursing homes or comparable institutions (12 months be-fore study and during study)
- •11.Pregnancy and lactation
- •12.Women of childbearing age, who do not use a medically accepted method of contraceptional method unless in case of post-hysterecomy or sterilized partner or menopause with last period at least 6 months prior to study start
- •13.Current or previous abuse of alcohol or drugs
- •14.Patients in custody by juridical or official order.
- •15.Other severe physical or mental diseases which challenge the conduct of the study according to protocol or impact the evaluation of the efficacy or safety of the product or the safety of the patient
- •16.Patient is incapable of contracting or other circumstances which do not allow the patient to understand type, relevance and reach of the clinical trial
- •17.Unreliability or lack of cooperation by the patient
- •18.Other reasons against participation in the study in the opinion of the Investigator (e.g. patient’s physical or mental disability to collect a qualitative sample of midstream urine or to complete the diary)
- •19.Participation in another clinical study within 12 weeks prior to study start and during study
- •20.Patients who are part of the staff of the study centre, the Investigator him/herself or close relatives of the Investigator
研究者
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