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）是养老院居民最常见的感染。细菌尿在25-50%的女性养老院居民中普遍存在，其中90%还患有脓尿，细菌尿的抗生素治疗并没有降低发病率或死亡率。区分菌尿和有症状的UTI充满了临床诊断挑战。因此，抗生素管理是常见的推定UTI，导致多药耐药微生物的发展，药物相关的不良反应，和显着的成本。考虑到临床实践的现实，任何降低UTI发病率和死亡率的措施都应该包括预防菌尿和脓尿。以前的工作表明：1）蔓越莓成分减少细菌粘附体外尿路上皮细胞; 2）蔓越莓汁对年轻人和老年人的UTI预防有效 但在疗养院居民中作为长期干预可能不可行;和3）蔓越莓胶囊给药是可行的，并在短期监测期间被疗养院居民坚持，不良事件最少。本研究的主要目的是测试每天口服两粒酸果蔓胶囊预防疗养院女性居民细菌尿和脓尿的疗效。这一目标将通过在康涅狄格州女性养老院居民中进行一项为期12个月的双盲，随机，对照试验，每天口服两粒蔓越莓胶囊与安慰剂。次要目的是比较蔓越莓胶囊与安慰剂组尿路特异性症状的发生率。这一目标将通过每次获得尿样时评估尿路特异性症状来实现。主要假设是，与安慰剂相比，两个口服蔓越莓胶囊将与12个月内菌尿加脓尿发作相对减少33%相关。补充目的是确定：1）在12个月的监测期内每日口服蔓越莓胶囊的安全性; 2）疗养院居民和工作人员对管理方案的依从性; 3）蔓越莓和安慰剂组在12个月内不良临床结局的发生率。该设置将是10个康涅狄格州的疗养院，参与者将被招募。参与者将是65岁及以上的女性长期护理疗养院居民。主要结局将是菌尿加脓尿的存在，将每两个月通过清洁的捕获尿标本进行采样。泌尿道特异性症状的评估也将每两个月进行一次。检验主要假设的目标样本量为180名参与者，80%的把握度，I型错误为5%（双侧），以检测12个月监测期内菌尿加脓尿相对减少33%。本研究的目的是确定蔓越莓胶囊是否可以减少疗养院居民的菌尿加脓尿和与UTI相关的症状。这项研究的影响是，蔓越莓胶囊可能被证明是一种可行的和低风险的干预措施，以减少与UTI相关的不良临床结果在这个脆弱的人群。