EUCTR2013-000309-21-IT进行中（未招募）不适用
Antibiotic Prophylaxis and Renal Damage In Congenital abnormalities of the kidney and urinary Tract - PREDICT_Trial
AOU di Bologna, Policlinico S.Orsola-Malpighi0 个研究点目标入组 436 人开始时间: 2013年6月7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
- 入组人数
- 436
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
- •a.Age between 1 and 4 months
- •b.Gestational age > 35 weeks
- •c.Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2 at three months of age
- •d.No previous symptomatic UTI
- •e.Imaging Diagnostic work-up completed and presence of grade III to V vesico-ureteral reflux
- •f.Informed consent of parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 436
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a.Age <1 and >4 months
- •b.Gestational age < 35 weeks
- •c.Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age
- •d.Patients with neurogenic bladder, myelomeningocele, uretero-pelvic junction and/or uretero-vescico junction obstruction, or other malformations leading to potential voiding disturbances, apart from urethral valves
- •e.Patients with no or low grade reflux (grade I and II).
- •f.Hypersensitivity to the all the utilized antimicrobial agent
- •g.Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort.
- •h.Use of experimental drugs in the month previous to the beginning of the study
- •i.Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent.
研究者
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