EUCTR2014-000906-36-ES进行中（未招募）不适用
Randomized, parallel, multicenter, phase IV clinical trial to assess the efficacy of hyaluronic acid/chondroitin sulfate versus fosfomycin trometamol in recurrent urinary tract infection prevention. - INURE
aboratorios Gebro Pharma S.A.0 个研究点开始时间: 2014年10月3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
- Female
入选标准
- •- Females ? 18 years old
- •- At least 3 uncomplicated urinary infections documented by urine culture (>103 UFM/ml) in the last year
- •- Negative urine culture at the beginning of the trial.
- •- Fertile patient that agrees with abstinence or with the use of one contraceptive methods allowed during the trial. The allowed contraceptive methods are: intrauterine device (IUD), condoms, vasectomy and hormonal contraceptives.
- •- Females that give her 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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Any active infection at the beggining of the study.
- •- Infection history by fosfomycin trometamol resistant pathogens.
- •- Antibiotic prophylactic treatment at the moment of the inclusion.
- •- Treatment with HA-CS 1.6%/2.0% in the last 12 months.
- •- Increased postvoid residual (>100cc measured by suprapubic ecography)
- •- Demonstrated organic bladder pathology (bladder cancer, bladder lithiasis,?)
- •- Neurogenic bladder
- •- Urinary tract malformation.
- •- Pregnancy or breastfeeding.
- •- Use of diaphragm
- •- Use of spermicides
- •- Immunosuppression (corticoids, immunosuppressive therapy, immunosuppressive disease)
- •- Chronic renal failure, stage ?4.
- •- Allergy or intolerance to any of the studied drugs.
- •- Active vaginitis
- •- Patient with hormonal substitutive therapy and/or genital topic hormonal treatment.
- •- Recent urological intervention (in the last three months)
- •- Active neoplasic disease.
研究者
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