RIVUR Study

里弗研究

• 批准号: 8323113
• 负责人: TEJ K MATTOO
• 金额: $ 50.54万
• 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 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8323113
• 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; National Institute of Diabetes and Digestive and Kidney Diseases; 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; United States National Institutes of Health; 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%，在发热性尿路感染（UTI）后诊断时，患病率增至 30% - 40%。 VUR 容易引发尿路感染，并与肾脏疤痕相关，这可能导致高血压、蛋白尿和进行性肾损伤。目前 VUR 的治疗是长期抗菌预防，并在选定的病例中进行手术干预。然而，还没有精心设计的前瞻性研究来验证这种管理对患者是否有益。 2005 年 12 月，NIH/NIDDK 启动了针对儿童膀胱输尿管反流 (RIVUR) 的随机干预研究，这是一项多中心、随机、双盲、安慰剂对照试验，旨在确定每日抗菌药物预防在预防 I-IV 级 VUR 儿童复发性 UTI 和肾脏疤痕方面是否优于安慰剂。还对研究对象的细菌耐药性、便秘、排尿功能障碍、肾功能变化、生活质量、用药依从性和卫生资源的利用进行评估。收集血液和尿液储存库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接受每日抗菌预防（甲氧苄啶-磺胺甲恶唑）或安慰剂（每组 300 名），并进行为期 2 年的随访。该研究的招募工作于 2007 年 5 月开始，截至 2009 年 11 月 6 日，373 名患者（62%）已被随机分组​​，其中包括从底特律核心临床中心招募的 120 名患者中的 68 名患者（57%）。根据目前的招募预测，第 600 名参与者将在 2010 年 12 月之前被随机分配，需要对其进行随访直至 2012 年 12 月。然而，RIVUR 研究的当前资金将于 2010 年 5 月到期。该申请的主要目标是获得资金以确保持续的患者入组、评估、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，该研究已经随机分配了有史以来数量最多的最佳定义的幼儿队列 收集用于 VUR 的双盲、安慰剂对照研究。

项目成果

Risk Factors for the Development of Febrile Recurrences in Children with a History of Urinary Tract Infection.

• DOI: 10.1016/j.jpeds.2021.12.037
• 发表时间: 2022-04
• 期刊: The Journal of pediatrics
• 作者: Hum S;Liu H;Shaikh N
• 通讯作者: Shaikh N

Are prophylactic antibiotics indicated after a urinary tract infection?

尿路感染后是否需要预防性使用抗生素？

• DOI: 10.1097/mop.0b013e3283257d0f
• 发表时间: 2009
• 期刊: Current opinion in pediatrics
• 影响因子: 3.6
• 作者: Mattoo,TejK

Constipation on abdominal radiograph as potential risk factor for recurrent urinary tract infection development.

腹部X光片上的便秘是复发性尿路感染发展的潜在危险因素。

• DOI: 10.1007/s00467-021-04973-5
• 发表时间: 2021
• 期刊: Pediatric nephrology (Berlin, Germany)
• 作者: Muniz,Gysella;Kar,Erica;Gumus,Serter;Liu,Hui;Shaikh,Nader
• 通讯作者: Shaikh,Nader

Medical management of vesicoureteral reflux--quiz within the article. Don't overlook placebos.

• DOI: 10.1007/s00467-007-0485-3
• 发表时间: 2007-08
• 期刊: Pediatric nephrology (Berlin, Germany)
• 作者: Mattoo TK

Variation in the level of detail in pediatric voiding cystourethrogram reports.

儿科排尿性膀胱尿道造影报告的详细程度存在差异。

• DOI: 10.1016/j.jpurol.2016.08.025
• 发表时间: 2017
• 期刊: Journal of pediatric urology
• 影响因子: 2
• 作者: Schaeffer,AnthonyJ;Chow,JeanneS;Ivanova,Anastasia;Cui,Gang;Greenfield,SaulP;Zerin,JMichael;Hoberman,Alejandro;Mathews,RanjivI;Mattoo,TejK;Carpenter,MyraA;Moxey-Mims,Marva;Chesney,RussellW;Nelson,CalebP
• 通讯作者: Nelson,CalebP