NCT00200616已完成不适用
Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- End point : recurrence of urinary tract infection during the study period (0 è 18 months)
研究概览
简要总结
Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).
详细描述
A voiding cystourethrogram was performed for each child less than 3 years old with a first urinary tract infection. In case of vesico-ureteral reflux, a randomization was done between continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no antibioprophylaxis. Duration of follow up was 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children less than 3 years old
- •First proved urinary tract infectionIsolated vesico-ureteral reflux
- •Parents have been fully informed and have given written informed consent to participate in the study
排除标准
- 未提供
结局指标
主要结局
End point : recurrence of urinary tract infection during the study period (0 è 18 months)
次要结局
- 1) Type of urinary tract infection (pyelonephritis or cystitis)
- 2) Evaluation of the quality of life with a validated questionnaire done at 9 months
研究者
研究点 (1)
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