Randomized Intervention for VesicolUreteral Reflux (RIVUR) Study

膀胱输尿管反流 (RIVUR) 研究的随机干预

• 批准号: 7992032
• 负责人: RON KEREN
• 金额: $ 49.93万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 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/7992032
• 关键词: Award; Child; Clinical Trials; Clinical Trials Design; Data Analyses; Diagnosis; Enrollment; Fever; Funding; Grant; Intervention; Manuscripts; Measures; Outcome; Placebos; Preparation; Prophylactic treatment; Protocols documentation; Randomized; Randomized Controlled Trials; Recurrence; Reflux; Renal function; Research Personnel; Resources; Site; Time; Treatment Failure; Urinary tract infection; Vesico-Ureteral Reflux; antimicrobial; drug resistant bacteria; health related quality of life; meetings; prevent; renal scarring

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.

膀胱输尿管反流儿童随机干预 (RIVUR) 试验于 2005 年 9 月 30 日资助。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，每日使用 TMP/SMZ 进行抗菌预防是否优于安慰剂，以预防复发性尿路感染 (UTI)。 RIVUR 还将评估在研究结束时抗菌药物预防在改变肾脏疤痕水平方面是否优于安慰剂。该研究的其他目的包括评估与治疗失败、耐药细菌的存在、与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有症状 UTI 后患有 I-IV 级 VUR 的儿童，但在最初的奖励期内未达到招募目标。迄今为止，所有临床试验中心已招募了约 400 名儿童。招募预测表明，3 年的延续补助金将允许 600 名儿童成功注册，对最后注册的儿童进行 2 年的跟踪，并有剩余时间完成数据分析和手稿准备。