Efficacy of Prophylactic Antimicrobials in Children with Vesicoureteral Reflux

预防性抗菌药物对膀胱输尿管反流儿童的疗效

• 批准号: 7457904
• 负责人: ALEJANDRO HOBERMAN
• 金额: $ 58.37万
• 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 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7457904
• 关键词: Accident and Emergency department; Accounting; Acute; Address; Adherence; Admission activity; Adoption; Advocate; Affect; Age; Age-Months; Antibiotic Therapy; Antimicrobial Resistance; Area; Awareness; Bacteriuria; Caring; Catheters; Characteristics; Child; Childhood; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Data Monitoring Committees; Communicable Diseases; Communities; Community Networks; Consent; Controlled Clinical Trials; Cost Effectiveness Analysis; DMSA; Detection; Deterioration; Diagnosis; Diagnostic Imaging; Discipline; Double-Blind Method; Drug resistance; Early Diagnosis; Eclampsia; Economic Burden; Effectiveness; Electronics; Emergency Medicine; End stage renal failure; Enrollment; Evaluation; Feces; Fever; Follow-Up Studies; Funding Mechanisms; Goals; Health Personnel; Hematogenous; Hematological Disease; Hospitalization; Hospitals; Hour; Hypertension; Image; Imaging Techniques; Incidence; Infant; Infection; Interdisciplinary Study; Interobserver Variability; Intervention; Intravenous; Invasive; Investments; Kidney; Laboratories; Lead; Life; Link; Measures; Medical; Medical center; Minimum Inhibitory Concentration measurement; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Numbers; Office Visits; Operative Surgical Procedures; Oral; Organism; Otitis Media; Outcome; Outpatients; Pathway interactions; Patient observation; Patients; Pediatric Hospitals; Pediatrics; Penicillins; Personal Satisfaction; Placebo Control; Placebos; Positioning Attribute; Practice based research; Prevalence; Primary Health Care; Procedures; Prophylactic treatment; Provider; Pyuria; Qualifying; Randomized; Randomized Clinical Trials; Rate; Recruitment Activity; Renal function; Research; Research Methodology; Research Personnel; Resistance; Resources; Risk; Role; Scanning; Science; Screening procedure; Selection Bias; Severity of illness; Source; Specimen; Standards of Weights and Measures; Streptococcus pneumoniae; Syndrome; Techniques; Testing; Time; Treatment Failure; U-Series Cooperative Agreements; Ultrasonography; United States National Institutes of Health; Universities; Upper arm; Urinalysis; Urinary tract infection; Urine; Urology; Vesico-Ureteral Reflux; Vision; Visit; Week; Work; acute pyelonephritis; age group; aged; antimicrobial; base; concept; design; disorder prevention; experience; follow-up; health related quality of life; implantation; improved; indexing; influenza virus vaccine; interest; point of care; prenatal; prevent; prophylactic; renal scarring; sex; treatment center; urinary tract obstruction; urologic; willingness

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）每年影响美国2.6%至3.4%的儿童，每年有超过100万人次就诊，94，000人次医院门诊就诊和40，000人次住院。仅UTI住院治疗的经济负担总计1.8亿美元。膀胱输尿管反流（VUR）发生在35%的UTI儿童中，增加了感染和长期后遗症的风险。本建议旨在评估管理策略在改善VUR儿童结局方面的有效性。持续的抗菌预防已成为VUR儿童的公认治疗，尽管缺乏证据支持这种做法。同样，输尿管内镜手术的作用也没有得到适当的评价。实践中的最新变化强调了确定预防性抗菌药物疗效的重要性。其中包括：1）早期诊断和治疗尿路感染，减少肾瘢痕形成，2）父母意识到抗生素耐药性增加，愿意遵循“观察等待”的路径; 3）产前通过广泛使用超声识别尿路功能性和解剖学阻塞（将这些儿童与那些在索引尿路感染后诊断为VUR的儿童分开）。该提案包括一项多中心、随机、安慰剂对照、双盲临床试验，旨在评价预防性抗菌药物在预防2-36个月VUR儿童肾瘢痕形成和再感染方面的疗效。患有1 - 111级VUR的儿童将随机接受预防性抗菌治疗或安慰剂;可以容易地添加第三组以评估输尿管内窥镜手术的疗效。患有IV-V级VUR的儿童将接受抗生素预防，因为他们有最高的肾瘢痕形成风险。将从1）急性护理途径和2）转诊护理途径招募儿童，以提高研究结果的普遍性。匹兹堡儿童医院作为一个儿科肾脏病/泌尿科临床治疗中心，在参与这项合作协议方面处于独特的地位。我们的特色包括：1）一支由经验丰富的临床研究者组成的跨学科团队，代表了各个亚专业，2）在儿科UTI和VUR的临床研究成就方面有着良好的记录，3）在研究方法以及招募和保留大量儿童参与临床试验方面拥有丰富的专业知识