A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections.
研究概览
简要总结
Children who present with pyelonephritis undergo many investigations, and long term care to prevent renal damage. The focus is primarily on preventing renal failure however along the way and particularly with children, other issues arise which impact their lives, as well as their family's lives. Parents are concerned about subjecting their children to invasive procedures and long term antibiotic use, particularly if they are not sure of the benefit. This study seeks to provide information on the impact of investigation and long term antibiotic treatment in reference to long term health and quality of life in children who present with febrile urinary tract infections in the absence of anatomic abnormalities.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 0 to 12 years of age presenting with first episode of acute pyelonephritis in the absence of vesicoureteral reflux.
- •Acute pyelonephritis defined as presence of fever, a positive urine culture (growth of a single urinary tract pathogen at =10(8) CFU/ml for catheterization specimens and =10(4) CFU/ml for clean catch specimens), and a positive DMSA scan (a discreet defect or generalized decrease in activity).
排除标准
- •Neurogenic bladder
- •anatomic congenital anomaly
- •allergy to all prophylactic antibiotics
- •children whose parents do not wish to participate
研究组 & 干预措施
A
Eligible children will be randomized to antibiotic prophylaxis. Children under 3 months will receive amoxicillin 10mg/kg once per day. Children >3months will receive Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component). Those children with a Sulfa allergy will receive nitrofurantoin (1mg/kg) once per day.
干预措施: Trimethoprim Sulfamethoxazole (Drug)
B
Eligible children will then be randomized to placebo.
干预措施: placebo (Drug)
结局指标
主要结局
To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections.
时间窗: one year
次要结局
- To determine whether recurrent infections and involvement with the medical system impacts quality of life by assessing how this medical condition affects children using standardized quality of life questionnaires.(Yearly for five years)
- To determine whether antibiotic prophylaxis prevents long-term renal scarring by assessing results of DMSA scans to look at long term renal scarring.(One year and five years)
研究者
Darcie Kiddoo
Physician
University of Alberta