RIVUR Study

里弗研究

• 批准号: 7992649
• 负责人: TEJ K MATTOO
• 金额: $ 63.74万
• 依托单位: WAYNE STATE 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/7992649
• 关键词: Ancillary Study; Blood; Child; Clinical Trials Design; Constipation; Data Collection; Diagnosis; Double-Blind Method; Enrollment; Ensure; Evaluation; Fever; Functional disorder; Funding; Health Resources; Hypertension; Intervention; Kidney; Operative Surgical Procedures; Other Genetics; Participant; Patients; Placebos; Prevalence; Principal Investigator; Prophylactic treatment; Prospective Studies; Proteinuria; Quality of life; Randomized; Recruitment Activity; Recurrence; Reflux; Renal function; Research Design; Role; Sampling; Study Subject; Testing; Trimethoprim-Sulfamethoxazole; Urinary tract infection; Urine; Vesico-Ureteral Reflux; antimicrobial; bacterial resistance; base; clinical research site; cohort; design; double-blind placebo controlled trial; follow-up; medication compliance; placebo controlled study; prevent; renal scarring; repository; urologic

Primary vesicoureteric reflux (VUR) is the most common urological abnormality in children, with a prevalence of about one percent, which increases to 30%- 40% when diagnosed after febrile urinary tract infection (UTI). VUR predisposes to UTI and is associated with renal scarring, which may cause hypertension, proteinuria, and progressive renal damage. The current treatment of VUR is long-term antimicrobial prophylaxis with surgical intervention in selected cases. However, there has been no well-designed prospective study to validate that this management is beneficial to the patient. In December 2005, NIH/NIDDK initiated the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) study, which is a multicenter, randomized, double-blind, placebo-controlled trial designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrent UTI and renal scarring in children with grade l-IV VUR. The study subjects are also evaluated for bacterial resistance, constipation, voiding dysfunction, changes in renal function, quality of life, medication compliance, and the utilization of health resources. Blood and urine repository samples are collected for genetic and other ancillary studies. To test the study hypotheses, a total of 600 children will be randomly assigned to daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo (300 in each group) and followed for a 2-year period. The recruitment for the study started in May 2007 and as of November 6, 2009, 373 (62%) patients have been randomized, which includes 68 (57%) of the 120 patients to be recruited from Detroit Core Clinical Site. Based on the current recruitment projections, the 600th participant will be randomized by December 2010, who will need to be followed until December 2012. However, the current funding for the RIVUR study expires in May 2010. The main objective of this application is to obtain funding to ensure continued patient enrollment, evaluation, follow-up, and data collection for a successful completion of this very important and uniquely designed study, which has already randomized the largest number of best defined cohort of young children ever collected for a double-blind, placebo controlled, study on VUR.

原发性膀胱输尿管反流（VUR）是儿童最常见的泌尿系统异常，患病率约为1%，当在发热性尿路感染（UTI）后诊断时，患病率增加到30%- 40%。VUR易发生UTI，并与肾瘢痕形成相关，后者可能导致高血压、蛋白尿和进行性肾损害。VUR目前的治疗方法是长期的抗菌预防，并在选定的病例中进行手术干预。然而，目前还没有设计良好的前瞻性研究来验证这种管理对患者有益。2005年12月，NIH/NIDDK启动了膀胱输尿管反流儿童随机干预（RIVUR）研究，这是一项多中心、随机、双盲、安慰剂对照试验，旨在确定每日抗菌预防在预防l-IV级VUR儿童复发性UTI和肾瘢痕方面是否上级安慰剂。还评价研究受试者的细菌抗性、便秘、排尿功能障碍、肾功能变化、生活质量、药物依从性和卫生资源利用。收集血液和尿液储存样本用于遗传和其他辅助研究。为了检验研究假设，总共600名儿童将被随机分配到每日抗生素预防（甲氧苄啶-磺胺甲恶唑）或安慰剂组（每组300名），并随访2年。本研究的招募于2007年5月开始，截至2009年11月6日，373例（62%）患者接受了随机化，其中包括从底特律核心临床研究中心招募的120例患者中的68例（57%）。根据目前的招募预测，第600例受试者将在2010年12月前随机分配，需要随访至2012年12月。然而，目前对RIVUR研究的资助将于2010年5月到期。本申请的主要目的是获得资金，以确保持续的患者入组、评价、随访和数据收集，以成功完成这项非常重要且设计独特的研究，该研究已经随机化了最大数量的最佳定义的幼儿队列，用于VUR的双盲、安慰剂对照研究。