Limited Competition for Continuation of RIVUR

RIVUR 延续的有限竞争

• 批准号: 8123290
• 负责人: SAUL Philip GREENFIELD
• 金额: $ 82.4万
• 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 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8123290
• 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。如果得不到诊断和治疗，可能会导致尿路感染复发和肾脏疤痕形成，进而导致高血压和肾功能不全。大多数较低级别的VUR会随着生长而消失，但这可能需要很多年的时间。治疗方法仍然存在争议，包括观察、长期抗生素预防和手术矫正。最近，用于外科矫正的微创技术已经被开发出来，这导致了更广泛的干预，这可能是不合适的或不必要的。到目前为止，治疗算法一直基于没有统计学相关性的非随机、非对照研究或试验。随机干预膀胱输尿管反流儿童试验设计为双盲、随机、统计学相关研究，比较1个月至6岁L-IV级膀胱输尿管反流患儿服用安慰剂和长期抗生素预防的效果。这是同类研究中唯一的一项。该项目最初于2005年获得资金，计划于2010年完工。随机分组后，对儿童进行2年的观察。方案制定和放射学初步研究在最初的一年半期间取得了进展；大多数临床站点在2007年启动。为了达到诊断的准确性，许多临床部位的放射成像技术必须加以改进。统计分析确定，每个手臂需要300名患者才能达到足够的统计能力。制定了严格的入选标准，特别是关于尿路感染的诊断以及尿路感染指数和输尿管返流的放射学发现之间的时间。目前，只有不到400名患者被随机分组，正因为如此，RIVUR试验将延长至2013年。总部位于布法罗的财团是5个临床中心之一，最初的任务是每个中心招收120名儿童。我们还没有达到这个目标，我们已经招收了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名的学生，我们希望在2010年初开始这样做。预计来自RIVUR试验的数据将使VUR儿童能够得到适当的治疗和利用卫生保健资源。