Randomized Intervention for VesicolUreteral Reflux (RIVUR) Study

儿童膀胱输尿管反流的随机干预试验(RIVUR)于2005年9月30日获得资助。RIVUR研究是一项多中心随机对照试验，旨在确定在诊断为膀胱输尿管反流(VUR)的儿童中，每天使用TMP/SMZ进行抗菌预防是否优于安慰剂预防复发的尿路感染(UTI)。RIVUR还将评估在改变研究结束时肾脏瘢痕形成的水平方面，抗菌素预防措施是否优于安慰剂。这项研究的其他目的包括评估与治疗失败有关的结果、耐药细菌的存在、与健康相关的生活质量、资源利用和肾功能指标。研究调查人员计划招募600名患有L-IV级VUR的儿童，这些儿童在第一次或第二次发烧或有症状的尿路感染后，但在最初的奖励期间没有达到入学目标。到目前为止，所有临床试验地点已经招募了大约400名儿童。征聘预测表明，三年延续补助金将使600名儿童成功入学，最后一名入学儿童的两年复读期，还有时间完成数据分析和手稿编写。

The Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial was funded September 30, 2005. The RIVUR study is a multi-center, randomized controlled trial designed to determine whether daily antimicrobial prophylaxis with TMP/SMZ is superior to placebo in preventing recurrent urinary tract infection (UTI) in children diagnosed with vesicoureteral reflux (VUR). RIVUR will also evaluate whether antimicrobial prophylaxis is superior to placebo in modifying the level of renal scarring present at the end of the study. Other aims of the study include evaluating outcomes related to treatment failures, presence of drug resistant bacteria, health-related quality of life, resource utilization, and measures of renal function. Study investigators planned to enroll 600 children with grades l-IV VUR following first or second febrile or symptomatic UTI, but the enrollment target was not met during the original award period. To date, approximately 400 children have been enrolled across all the clinical trial sites. Recruitment projections indicate that the 3-year continuation grant would allow successful enrollment of 600 children , 2-year follow p of the last enrolled child, with time remaining to complete the data analysis and manuscript preparation.