Randomized Intervention for Vesicoureteral Reflux (RIVUR)

膀胱输尿管反流随机干预 (RIVUR)

• 批准号: 8123366
• 负责人: Myra A. Carpenter
• 金额: $ 123.16万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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/8123366
• 关键词: Bar Codes; Biometry; Case Report Form; Child; Clinical Trials Design; Commit; Data; Data Quality; Databases; Diagnosis; Documentation; Enrollment; Evaluation; Fever; Informed Consent; Intervention; Label; Life Cycle Stages; Manuals; Manuscripts; Measures; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; North Carolina; Online Systems; Outcome; Participant; Placebos; Process; Prophylactic treatment; Protocols documentation; Publications; Randomized; Recurrence; Renal function; Reporting; Research Infrastructure; Research Personnel; Resources; Retrieval; Shipping; Ships; Specimen; Symptoms; System; Treatment Failure; Universities; Update; Urinary tract infection; Vesico-Ureteral Reflux; Vial device; Writing; antimicrobial; data management; drug resistant bacteria; electronic data; experience; follow-up; health related quality of life; meetings; operation; prevent; programs; quality assurance; renal scarring; sample collection; symposium; web site

The primary objective of the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial is to establish whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrent urinary tract infection (UTI) in children diagnosed with vesicoureteral reflux (VUR) who receive early evaluation of UTI symptoms. 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 plan to enroll 600 children with grades l-IV VUR following first or second febrile or symptomatic UTI. Enrollment and two-year treatment and follow-up are on-going. This proposal is to continue serving as the DCC, providing scientific, data management, statistical analysis, quality assurance, and logistical support to the trial network. The Collaborative Studies Coordinating Center in the Department of Biostatistics at the University of North Carolina will continue to provide scientific direction for the study through participation in study committees; provide statistical expertise for all aspects of trial design, monitoring and analysis; perform statistical analyses for reports, presentations and publications; provide, maintain and enhance the web-based data management system; distribute monthly reports on study recruitment, retention and data quality; direct a trial-wide quality assurance program; coordinate the specimen collection and shipping activities; provide and support the trial research infrastructure, including maintaining and updating as necessary the trial protocol, manual of operations, case report forms, website, and providing logistical support for study meetings and conference calls; and at the conclusion of the project, submit data as directed to the NIDDK data repository. DCC investigators and staff will initiate, participate in, and support manuscript writing groups.

囊泡级反流（RIVUR）试验的随机干预的主要目标是确定每天的抗菌预防性预防是否优于安慰剂，在预防诊断为囊泡型养殖（VUR）的儿童的复发性尿路感染（UTI）方面是否优于安慰剂（UTI）。 Rivur还将评估抗菌预防是否优于安慰剂，以改变研究结束时存在的肾脏疤痕水平。该研究的其他目的包括评估与治疗失败有关的结果，耐药细菌的存在，与健康相关的生活质量，资源利用以及肾功能的度量。研究研究人员计划在第一次或第二次发热或有症状的UTI之后招募600名L-IV VUR等级的儿童。入学率和两年的治疗和随访正在进行中。该建议将继续担任DCC，为试验网络提供科学，数据管理，统计分析，质量保证和后勤支持。北卡罗来纳大学生物统计学系协作中心的合作研究将继续通过参加研究委员会为研究提供科学方向；为试验设计，监测和分析的各个方面提供统计专业知识；对报告，演示和出版物进行统计分析；提供，维护和增强基于Web的数据管理系统；分发有关研究招聘，保留和数据质量的每月报告；指挥试验范围内的质量保证计划；协调标本收集和运输活动；提供和支持试用研究基础架构，包括在必要时维护和更新，试用协议，操作手册，案例报告表格，网站，为研究会议和电话会议提供后勤支持；在项目结束时，将数据按照指示提交给NIDDK数据存储库。 DCC调查人员和工作人员将启动，参与和支持手稿写作小组。