Limited Competition for Continuation of RIVUR

RIVUR 延续的有限竞争

• 批准号: 8323109
• 负责人: SAUL Philip GREENFIELD
• 金额: $ 69.61万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 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 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8323109
• 关键词: 6 year old; Algorithms; Antibiotic Prophylaxis; Buffaloes; Child; Clinical; Data; Diagnosis; Double-Blind Method; Enrollment; Funding; Goals; Growth; Healthcare; Hypertension; Imaging Techniques; Intervention; Kidney Failure; Lead; Operative Surgical Procedures; Patients; Pilot Projects; Placebos; Prophylactic treatment; Randomized; Recurrence; Resources; Techniques; Time; Uncontrolled Study; Urinary tract infection; Vesico-Ureteral Reflux; arm; base; clinical research site; design; diagnostic accuracy; health care service utilization; indexing; minimally invasive; protocol development; renal scarring

Vesicoureteral reflux (VUR) is the most common congenital anomaly associated with urinary tract infection (UTI) in children. If unrecognized and untreated it can lead to recurrent UTI and renal scarring, which in turn can be the cause of hypertension and renal insufficiency. Most cases of lower grade VUR resolve with growth, but this can take many years. Treatment remains controversial and includes observation, long term antibiotic prophylaxis and surgical correction. More recently, minimally invasive techniques for surgical correction have been developed and this has led to more widespread intervention, which may not be appropriate or necessary. Until now treatment algorithms have been based on non-randomized, uncontrolled studies or trials without statistical relevance. The RIVUR (Randomized Intervention for children with Vesicoureteral Reflux) trial was designed as a double blind, randomized, statistically relevant study, comparing placebo to long term antibiotic prophylaxis in children with grades l-IV VUR in children 1 month to 6 years of age. It is the only study of its kind. It was initially funded in 2005 and meant to be completed in 2010. After randomization, children are observed for 2 years. Protocol development and radiologic pilot studies progressed over the first 1 1/2 years; most clinical sites were activated in 2007. Radiologic imaging techniques had to be modified at a number of clinical sites to achieve diagnostic accuracy. Statistical analysis determined that 300 patients were needed in each arm to achieve adequate statistical power. Strict entrance criteria were developed, especially regarding the diagnosis of UTI and timing between the index UTI and radiologic discovery of VUR. At present fewer than 400 patients have been randomized and it is for that reason that the RIVUR trial is being extended to 2013. The Buffalo-based consortium is one of 5 clinical centers that were initially tasked to enroll 120 children each. We are just shy of that goal and we have enrolled 113 children, more than any other, clinical center. Thus, we have been asked to enroll beyond 120, which we hope to begin doing early in 2010. It is anticipated that data from the RIVUR trial will enable appropriate treatment and utilization of health care resources for children with VUR.

膀胱输尿管反流（VUR）是儿童尿路感染（UTI）最常见的先天性异常。如果不及时发现和治疗，它会导致尿路感染和肾瘢痕的复发，这反过来又会导致高血压和肾功能不全。大多数低级别VUR病例随着生长而消退，但这可能需要多年时间。治疗方法仍有争议，包括观察、长期抗生素预防和手术矫正。最近，微创手术矫正技术得到了发展，这导致了更广泛的干预，这可能不是适当的或必要的。到目前为止，治疗算法都是基于非随机的、不受控制的研究或没有统计相关性的试验。RIVUR（膀胱输尿管反流儿童随机干预）试验设计为一项双盲、随机、统计学相关的研究，比较1个月至6岁的l-IV级VUR儿童的安慰剂和长期抗生素预防。这是同类研究中绝无仅有的。它最初于2005年获得资金，原定于2010年完工。随机分组后，对儿童进行为期2年的观察。方案制定和放射学试点研究在前一年半取得进展；大多数临床站点于2007年启动。放射成像技术必须在许多临床部位进行修改，以达到诊断的准确性。统计分析确定，每组需要300名患者才能达到足够的统计效果。制定了严格的进入标准，特别是关于UTI的诊断以及指数UTI和VUR放射学发现之间的时间。目前，只有不到400名患者被随机分配，因此RIVUR试验将延长至2013年。总部位于布法罗的联盟是五个临床中心之一，最初的任务是每个中心招收120名儿童。我们离这个目标只有一步之遥，我们已经招募了113名儿童，比其他任何临床中心都多。因此，我们被要求招收超过120人，我们希望在2010年初开始招收。预计来自RIVUR试验的数据将使患有VUR的儿童能够得到适当的治疗和卫生保健资源的利用。