NCT07229755已完成2 期
Comparison Between Effect of Empirical Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy in Children With Pyuria
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Decreased rate of urinary tract infection after Flexible ureteroscopy in Children
研究概览
简要总结
The aim of this study is to compare between effect of empirical antibiotic prophylaxis versus enhanced prophylactic measures on rate of urinary tract infection after Flexible ureteroscopy in Children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age starting from 4 up to 14 years old.
- •Patients with renal stones from 1cm to 1.5cm in largest dimensions (not more than 4 cm3 measured by CTUT) undergoing flexible URS.
排除标准
- •Patients who refuse to participate in the study.
- •Patients with single functioning kidney.
- •Patients with rising serum creatinine.
- •Known patient with neurogenic bladder.
- •Patients with DM type
- •Immunocompromised children.
- •Children with coagulopathy.
- •Patients with untreated UTI (or any interfering symptoms with UTI as fever or irritative LUTS).
研究组 & 干预措施
empirical antibiotic prophylaxis
Placebo Comparator
empirical antibiotic not culture guided
干预措施: Ceftriaxone (Rocephin®) (Drug)
empirical antibiotic prophylaxis
Placebo Comparator
empirical antibiotic not culture guided
干预措施: Levofloxacin (Device)
enhanced antibiotic prophylaxis
Experimental
干预措施: Ceftriaxone (Rocephin®) (Drug)
enhanced antibiotic prophylaxis
Experimental
干预措施: Levofloxacin (Device)
结局指标
主要结局
Decreased rate of urinary tract infection after Flexible ureteroscopy in Children
时间窗: From enrollment to the end of treatment at 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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