Randomized Intervention for Vesicoureteral Reflux (RIVUR)

膀胱输尿管反流随机干预 (RIVUR)

• 批准号: 7991982
• 负责人: Myra A. Carpenter
• 金额: $ 95.9万
• 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/7991982
• 关键词: Bar Codes; Biometry; Case Report Form; Child; Clinical Trials Design; Commit; Data; Data Quality; Databases; Diagnosis; Distributed Systems; 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; 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.

膀胱输尿管反流儿童随机干预 (RIVUR) 试验的主要目的是确定每日抗菌药物预防在预防膀胱输尿管反流 (VUR) 儿童复发性尿路感染 (UTI) 方面是否优于安慰剂，这些儿童接受早期评估尿路感染症状。 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。入组以及两年的治疗和随访正在进行中。该提议是继续充当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合作研究协调中心将通过参与研究委员会继续为该研究提供科学方向；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、演示文稿和出版物进行统计分析；提供、维护和增强基于网络的数据管理系统；分发有关研究招募、保留和数据质量的月度报告；指导整个试验范围内的质量保证计划；协调标本采集和运输活动；提供和支持试验研究基础设施，包括根据需要维护和更新试验方案、操作手册、病例报告表、网站，并为研究会议和电话会议提供后勤支持；项目结束时，按照指示向 NIDDK 数据存储库提交数据。 DCC 调查员和工作人员将发起、参与和支持稿件写作小组。