EUCTR2011-004594-82-BG进行中（未招募）不适用
Efficacy of an intravesical instillation with neomycin solution in acute cystitis: a double-blind, placebo-controlled trial in patients with permanent intravesical catheter - Efficacy of intravesical instillation of neomycin solution in patients with acute cystitis and intra
Schur Pharmazeutika GmbH & Co. KG0 个研究点开始时间: 2011年10月20日最近更新:
适应症
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] 18 years and older
- •[2] Patients with long term indwelling intravesical catheter (urethral or suprapubic) in place for at least 28 days
- •[3] Patients with significant bacteriuria defined as =10^5 CFU/ml
- •determined bymeans of Uricult® Trio test (CLED medium)
- •[4] Patients with ability to follow study instructions and likely to attend
- •and complete all required visits
- •[5] Written informed consent of the patient
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. Hypersensitivity to the active substances or to any of the excipients of
- •the study drug, or to any related drug
- •2. Severe urinary tract infection (e.g. with fever of >39°C) which
- •requires systemic antibacterial treatment
- •3. Urinary tract infection other than cystitis: pyelonephritis, prostatitis
- •4. Urinary tract infection caused by or associated with nephrolithiasis
- •5. Cystitis caused by or associated with urolithiasis of the bladder
- •6. Exchange of the intravesical catheter during the trial
- •7. Patients with chronic kidney disease of stage 3 or higher: glomerular
- •filtration rate of less than 60 ml/min or serum creatinine above 150 µmol/l
- •8. Treatment with systemic antibiotics within the last 14 days before
- •screening or during the trial
- •9. Intravesical administration of antibacterial medication (including disinfectants like povidone iodine or similar) within the last 4 days before screening or during the trial
- •10. Administration into the catheter of antibacterial medication
- •(including disinfectants like povidone iodine or similar) during the trial
- •11. Indwelling intravesical catheter with an antibacterial internal coating
- •12. Inability to contain the trial medication in the urinary bladder for at
- •least 60 minutes on more than 2 occasions
- •13. Lesions of the epithelium of the urinary bladder
- •14. Hearing or vestibular impairment
- •15. Myasthenia gravis
- •16. Concomitant intake/administration of muscle relaxing agents
- •17. Pregnancy or lactation
- •18. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
- •19. Severe physical or mental concomitant diseases that might ham-per
- •the realization of the trial according to protocol
- •20. Legal incapacity and/or other circumstances rendering the patient
- •unable to understand the nature, scope and possible consequences of the study
- •21. Unreliability or lack of cooperation
研究者
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