Randomized Intervention for Vesico-Ureteral Reflux (RIVUR) Trial

膀胱输尿管反流儿童的随机干预（RIVUR）研究于2005年启动，旨在评估出生至6岁之间诊断为发热性尿路感染（UTI）后膀胱输尿管反流（VUR）的儿童抗菌药物预防的效果。通过排尿膀胱尿道造影（VCU）确定有1或2例发热性或症状性尿路感染的600名儿童被随机分为甲氧苄氨嘧啶/磺胺甲恶唑（TMP/SMZ）或安慰剂进行抗菌预防治疗。进入研究的儿童通过初始二巯基琥珀酸（DMSA）肾脏扫描来评估肾脏疤痕的存在。随访评估每2个月进行一次电话联系，每6个月进行一次门诊检查。在研究结束时进行VCU以确定VUR的持久性/分辨率。在12个月和研究结束24个月时进行DMSA肾脏扫描，以确定肾脏瘢痕的新发。此外，通过使用随访时获得的粪便培养物来评估抗生素耐药性的发展。研究的主要目的是确定抗生素预防的使用是否(i)减少尿路感染的发生率或延迟尿路感染复发的时间，（ii）增加耐药大肠杆菌的发展或增加大肠杆菌引起的尿路感染的发生率，以及（iii）导致肾瘢痕形成的减少。RIVUR研究的方案是由来自五个核心临床中心和数据协调中心的研究人员以及NIH/NIDDK的输入达成的共识。截至2009年10月，已有370名儿童被招募到这项研究中，并被跟踪了2年。延长研究期的主要目的是完成研究队列的招募和随访。

The Randomized Intervention for children with Vesicoureteral Reflux (RIVUR) Study was initiated in 2005 to assess the efficacy of antimicrobial prophylaxis in children between birth and 6 years of age diagnosed with vesicoureteral reflux (VUR) following a febrile urinary tract infection (UTI). Six hundred children identified following one or two febrile or symptomatic UTIs, who are identified as having VUR using voiding cystourethrography (VCU), are randomized to antimicrobial prophylaxis with trimethoprim/sulfamethoxazole (TMP/SMZ) or placebo. Children that are entered into the study are evaluated with initial dimercaptosuccinate (DMSA) renal scan to determine for the presence of renal scarring. Follow-up evaluation is performed with telephone contacts every 2 months and clinic visits every 6 months. VCU is performed at study end to determine persistence/resolution of VUR. DMSA renal scan is performed at 12 months and at study end at 24 months to determine new onset of renal scarring. Additionally, development of antibiotic resistance is assessed with the use of fecal cultures obtained at follow-up visits. Primary study aims are to determine if the use of antibiotic prophylaxis (i) reduces the incidence of UTI or delays the time to recurrent UTIs in children with VUR, (ii) increases the development of resistant E. coli or increases the incidence of UTIs caused by E. coli and (iii) leads to reduction in the development of renal scarring. The protocol of the RIVUR study was developed as a consensus between the investigators from five core clinical centers and the data coordinating center along with input from the NIH/NIDDK. As of October 2009, 370 children have been recruited into the study and are being followed for 2 years. The primary aim of the extension is to complete recruitment and follow-up of the study cohort.