Randomized Intervention for Vesico-Ureteral Reflux (RIVUR) Trial

儿童膀胱输尿管反流的随机干预(RIVUR)研究始于2005年，目的是评估从出生到6岁的儿童在发热尿路感染(UTI)后被诊断为膀胱输尿管反流(VUR)的抗菌药预防效果。在一到两次发热性或症状性尿路感染后确诊的600名儿童，经排尿膀胱尿路造影术(VCU)确诊为VUR，随机接受甲氧普林/磺胺甲恶唑(TMP/SMZ)或安慰剂的抗菌预防。对进入研究的儿童进行初始二硫代丁二酸酯(DMSA)肾脏扫描，以确定是否存在肾脏疤痕。随访评估每2个月进行一次电话接触，每6个月进行一次临床访问。在研究结束时进行VCU检查，以确定VUR的持续性/分辨率。在12个月时进行DMSA肾脏扫描，在研究结束时在24个月时进行扫描，以确定新出现的肾脏疤痕。此外，通过使用在后续访问中获得的粪便培养来评估抗生素耐药性的发展。主要研究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缓尿路感染的复发时间，(Ii)增加耐药大肠杆菌的发展或增加由大肠杆菌引起的尿路感染的发生率，以及(Iii)导致肾疤痕形成的减少。RIVUR研究的方案是由来自五个核心临床中心的研究人员和数据协调中心以及来自NIH/NIDDK的投入达成共识的。截至2009年10月，已有370名儿童被招募到这项研究中，并被跟踪了两年。延期的主要目的是完成研究队列的招募和后续行动。

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.