Randomized Intervention for Vesico-Ureteral Reflux (RIVUR) Trial

膀胱输尿管反流 (RIVUR) 随机干预试验

• 批准号: 7992490
• 负责人: Ranjiv I Mathews
• 金额: $ 18.18万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7992490
• 关键词: 6 year old; Antibiotic Prophylaxis; Antibiotic Resistance; Antimicrobial Resistance; Birth; Child; Clinic Visits; Clinical; Consensus; Data Collection; Data Coordinating Center; Development; Diagnosis; Escherichia coli; Evaluation; Fever; Follow-Up Studies; Incidence; Intervention; Kidney; Placebos; Principal Investigator; Prophylactic treatment; Protocols documentation; Randomized; Recruitment Activity; Recurrence; Research Personnel; Resistance development; Resolution; Scanning; Telephone; Time; Trimethoprim-Sulfamethoxazole; Urinary tract infection; Vesico-Ureteral Reflux; Visit; antimicrobial; cohort; follow-up; renal scarring

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.

膀胱输尿管反流儿童随机干预（RIVUR）研究于2005年启动，旨在评估出生至6岁之间发热性尿路感染（UTI）后诊断为膀胱输尿管反流（VUR）的儿童的抗菌预防疗效。600名儿童确定后，一个或两个发热或症状性尿路感染，谁被确定为VUR使用排尿膀胱尿道造影（VCU），随机接受抗菌预防甲氧苄啶/磺胺甲恶唑（TMP/SMZ）或安慰剂。进入研究的儿童进行评估与初始二巯基琥珀酸（DMSA）肾扫描，以确定是否存在肾瘢痕。每2个月通过电话联系进行一次随访评估，每6个月进行一次门诊访视。在研究结束时进行VCU，以确定VUR的持续性/消退。在12个月时和研究结束时24个月时进行DMSA肾扫描，以确定新的肾瘢痕形成。此外，使用随访访视时获得的粪便培养物评估抗生素耐药性的发展。主要研究目的是确定预防性使用抗生素是否（i）降低VUR儿童UTI的发生率或延迟UTI复发的时间，（ii）增加耐药大肠埃希菌的发展。或增加由大肠杆菌引起的UTI的发病率。大肠杆菌和（iii）导致减少肾瘢痕形成的发展。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者根据NIH/NIDDK的意见沿着达成的共识。截至2009年10月，已有370名儿童被招募参加这项研究，并接受了两年的随访。延期的主要目的是完成研究队列的招募和随访。