Cranberry Capsules for Prevention of UTI in Nursing Home Residents

蔓越莓胶囊预防疗养院居民尿路感染

• 批准号: 8845161
• 负责人: MANISHA JUTHANI-MEHTA
• 金额: $ 56.21万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-05-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8845161
• 关键词: Acute; Adherence; Adverse effects; Adverse event; Age; Antibiotic Therapy; Antibiotic-resistant organism; Antibiotics; Bacteriuria; Cause of Death; Cells; Chronic; Clinical; Connecticut; Cranberries; Development; Diagnostic; Double-Blind Method; Dysuria; Female; Frequencies; Goals; Healthcare; Hematuria; Hospitalization; In Vitro; Incidence; Incontinence; Infection; Infection prevention; Intervention; Juice; Leukocytes; Life; Long-Term Care; Methodology; Morbidity - disease rate; Nursing Homes; Oral; Outcome; Pain; Participant; Pharmaceutical Preparations; Placebos; Population; Prevention; Prevention strategy; Protocols documentation; Pyuria; Randomized; Randomized Controlled Trials; Recruitment Activity; Relative (related person); Risk; Safety; Sample Size; Sampling; Side; Specimen; Symptoms; Testing; Time; Urinary tract; Urinary tract infection; Urine; Vulnerable Populations; Woman; Work; arm; capsule; clinical practice; cohort; cost; efficacy testing; efficacy trial; follow-up; high risk; human old age (65+); innovation; milliliter; mortality; older women; prevent; primary outcome; young woman

DESCRIPTION (provided by applicant): Urinary tract infection (UTI) is the most common infection in nursing home residents. Bacteriuria is prevalent in 25-50% of female nursing home residents, 90% of whom also have pyuria, and antibiotic treatment of bacteriuria has not reduced morbidity or mortality. Differentiating bacteriuria from symptomatic UTI is fraught with clinical diagnostic challenges. Consequently, antibiotic administration is common for presumptive UTI, resulting in the development of multi-drug antibiotic-resistant organisms, drug-related adverse effects, and significant costs. Given the realities of clinical practice, any attemt at reducing morbidity and mortality from UTI should include preventing bacteriuria plus pyuria. Previous work has shown that: 1) cranberry components reduce bacterial adherence to uroepithelial cells in vitro; 2) cranberry juice is effective for UTI prevention in young and older women but may not be feasible as a chronic intervention among nursing home residents; and 3) cranberry capsule administration is feasible and adhered to by nursing home residents with minimal adverse events during a short term surveillance period. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day for prevention of bacteriuria plus pyuria in female nursing home residents. This aim will be accomplished by conducting a double-blind, randomized, controlled trial of two oral cranberry capsules per day versus placebo in a cohort of Connecticut female nursing home residents over 12 months. The secondary aim is to compare the occurrence of urinary tract specific symptoms in the cranberry capsule versus placebo groups. This aim will be accomplished by assessing urinary tract specific symptoms each time a urine sample is obtained. The primary hypothesis is that two oral cranberry capsules will be associated with a 33% relative reduction in episodes of bacteriuria plus pyuria over 12 months, compared to placebo. Supplementary aims are to determine the: 1) safety of administrating daily oral cranberry capsules over a 12 month surveillance period; 2) adherence of nursing home residents and staff to the administration protocol; and 3) incidence of adverse clinical outcomes in the cranberry and placebo arms over 12 months. The setting will be 10 Connecticut nursing homes from which participants will be recruited. The participants will be female long-term care nursing home residents age 65 years and older. The primary outcome will be presence of bacteriuria plus pyuria which will be sampled via clean catch urine specimen every two months. Assessment of urinary tract specific symptoms will be conducted every two months as well. The target sample size to test the primary hypothesis is 180 participants with 80% power, Type I error of 5% (2-sided), to detect a 33% relative reduction in bacteriuria plus pyuria over the 12 month surveillance period. The goal of this study is to determine if cranberry capsules can decrease bacteriuria plus pyuria and symptoms related to UTI among nursing home residents. The impact of this study is that cranberry capsules may prove to be a feasible and low risk intervention to reduce adverse clinical outcomes associated with UTI in this vulnerable population.

描述（由申请人提供）：尿路感染（UTI）是疗养院居民中最常见的感染。 25-50％的女性疗养院居民，其中90％患有脓尿性，细菌尿症普遍存在，菌毛尿症的抗生素治疗尚未降低发病率或死亡率。将细菌尿与症状性UTI区分开来，充满了临床诊断挑战。因此，抗生素给药对于推定UTI是常见的，导致多药抗生素的生物，与药物相关的不良反应和巨大成本的发展。鉴于临床实践的现实，任何降低UTI的发病率和死亡率的预示都应包括防止细菌和脓尿。先前的工作表明：1）蔓越莓成分在体外降低了细菌粘附到巨细胞上； 2）蔓越莓汁对年轻和年龄较大的年轻人预防UTI有效 妇女，但可能是养老院居民的长期干预措施的可行性； 3）蔓越莓胶囊给药是可行的，并且在短期监视期间，养老院居民的不良事件最小。这项研究的主要目的是测试每天两个口服蔓越莓胶囊的功效，以预防女性疗养院居民的杆菌和脓尿。这一目标将通过在12个月内每天在康涅狄格州女性养老院居民中进行两次口服蔓越莓胶囊，每天对两个口腔蔓越莓胶囊进行双盲，随机对照试验来实现。次要目的是比较酸果莓胶囊与安慰剂组中尿路特异性症状的发生。每次获得尿液样本时，都会通过评估尿路特定症状来实现此目标。主要假设是，与安慰剂相比，两个口腔蔓越莓胶囊将在12个月内相对减少33％的发作和脓尿。补充目的是确定：1​​）在12个月的监视期内管理每日口服蔓越莓胶囊的安全； 2）疗养院居民和员工遵守行政方案； 3）在12个月内，蔓越莓和安慰剂臂中不良临床结果的发生率。该环境将为10个康涅狄格州疗养院，从中招募参与者。参与者将是65岁及以上的女性长期护理疗养院居民。主要结果将是菌尿症加脓尿，每两个月将通过清洁尿液标本进行采样。尿路特定症状的评估也将每两个月进行一次。测试主要假设的目标样本量为180名参与者，功率为80％，I型误差为5％（2侧），以检测到12个月的监视期内杆菌和脓尿的相对减少33％。这项研究的目的是确定蔓越莓胶囊是否可以降低细菌尿症，脓尿和疗养院居民中与UTI有关的症状。这项研究的影响在于，蔓越莓胶囊可能被证明是一种可行且低风险的干预措施，可减少该脆弱人群中与UTI相关的不良临床结果。