Randomized Intervention for VesicolUreteral Reflux (RIVUR) Study

膀胱输尿管反流儿童随机干预（RIVUR）试验于2005年9月30日启动。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，每日使用TMP/SMZ抗菌药物预防复发性尿路感染（UTI）是否优于安慰剂。RIVUR还将评估在改变研究结束时存在的肾瘢痕水平方面，抗菌预防是否优于安慰剂。该研究的其他目的包括评估与治疗失败、耐药细菌的存在、健康相关的生活质量、资源利用和肾功能测量相关的结果。研究人员计划招募600名在第一次或第二次发热或症状性尿路感染后出现l-IV级VUR的儿童，但在最初的奖励期间没有达到招募目标。迄今为止，已在所有临床试验地点招募了大约400名儿童。招募预测表明，3年的持续资助将允许成功招募600名儿童，2年跟踪最后一名入组儿童，剩余时间完成数据分析和手稿准备。

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.