Prophylactic Antimicrobials in Children with Vesicoure

水囊尿儿童的预防性抗菌药物

• 批准号: 7036313
• 负责人: ALEJANDRO HOBERMAN
• 金额: $ 33.69万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 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 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7036313
• 关键词: antiinfective agents; chemoprevention; clinical research; clinical trials; cooperative study; disease /disorder prevention /control; human subject; human therapy evaluation; infant human (0-1 year); injury; kidney disorder; patient oriented research; pediatric pharmacology; pediatrics; preschool child (1-5); relapse /recurrence; scars; urinary bladder disorder; urinary tract imaging /visualization; urinary tract infection

DESCRIPTION (provided by applicant): Urinary tract infection (UTI) affects 2.6% to 3.4% of children in the US annually, and accounts for more than 1 million office visits, 94,000 hospital outpatient visits and (40,000 admissions each year. The economic burden just for UTI hospitalizations totals $180 million. Vesicoureteral reflux (VUR) occurs in 35% of children with UTI, increasing the risk of infection and long-term sequelae. This proposal aims to evaluate the effectiveness of management strategies in improving outcomes of children with VUR. Continuous antimicrobial prophylaxis has become accepted therapy for children with VUR, although scant evidence is available to support this practice. Similarly, the role of subureteral endoscopic surgery has not been properly evaluated. Recent changes in practice underscore the importance of determining the efficacy of prophylactic antimicrobials. These include: 1) earlier diagnosis and treatment of UTIs resulting in reduced renal scarring, 2) parental awareness of increased antimicrobial resistance and willingness to follow a "watchful waiting" path; and 3) prenatal identification of functional and anatomical obstructions of the urinary tract with widespread use of ultrasound (separating these children from those diagnosed with VUR following an index UTI). This proposal consists of a multicenter, randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of prophylactic antimicrobials in preventing renal scarring and reinfections in children aged 2-36 months old with VUR. Children with Grades l-lll VUR will be randomized to receive prophylactic antimicrobial therapy or placebo; a third arm could readily be added to evaluate the efficacy of subureteral endoscopic surgery. Children with grades IV-V VUR will receive antimicrobial prophylaxis because they have the highest risk of developing renal scarring. Children will be recruited from 1) an Acute Care Pathway and 2) a Referral Care Pathway to enhance generalizability of study findings. Children's Hospital of Pittsburgh is in a unique position to participate in this cooperative agreement as a pediatric nephrology/urology Clinical Treatment Center. Distinguishing features of our setting include 1) an interdisciplinary team of experienced clinical investigators representing the various subspecialties, which has 2) a strong record of clinical research accomplishments in pediatric UTI and VUR, and 3) extensive expertise in research methods and in recruiting and retaining a large number of children in clinical trials

描述（由申请人提供）： 尿路感染（UTI）每年在美国影响2.6％至3.4％的儿童，占100万以上的办公访问，94,000次医院医院的门诊就诊和（每年入院40,000次。旨在评估管理策略在改善VUR的儿童的结果中，尽管有很少的证据可以支持这种实践，但对这种实践的作用也没有适当评估包括：1）早期对UTI的诊断和治疗导致肾脏疤痕减少，2）父母对抗菌耐药性增加的意识以及遵循“注意等待”道路的意愿； 3）通过广泛使用超声检查尿路功能和解剖障碍的产前鉴定（将这些儿童与在指数UTI后被诊断为VUR的孩子分开）。该提案包括一个多中心，随机，安慰剂对照，双盲临床试验，以评估预防性抗菌剂在防止2-36个月大的儿童中预防肾脏疤痕和恢复肾脏疤痕和恢复的疗效。 L-LLL VUR等级的儿童将被随机分配以接受预防性抗菌治疗或安慰剂；可以很容易地添加第三臂以评估腹部内窥镜手术的功效。具有IV-V VUR等级的儿童将获得抗菌预防，因为他们的肾脏疤痕风险最高。儿童将从1）急性护理途径和2）提高研究结果的普遍性的转诊护理途径招募。匹兹堡儿童医院处于独特的地位，可以作为儿科肾脏病/泌尿科临床治疗中心参加这一合作协议。我们设置的区分特征包括1）代表各种亚科的经验丰富的临床研究人员组成的跨学科团队，其中2）具有儿科UTI和VUR临床研究成就的良好记录，以及3）3）在研究方法以及招募和招募和保留临床试验中大量儿童方面的广泛专业知识