Cranberry Capsules for Prevention of UTI in Nursing Home Residents

描述(申请人提供)：尿路感染(UTI)是疗养院居民最常见的感染。菌尿在25%-50%的女性养老院居民中普遍存在，其中90%的人也有脓尿，而抗生素治疗菌尿并不能降低发病率或死亡率。区分菌尿和症状性尿路感染充满了临床诊断方面的挑战。因此，抗生素给药对于推定的尿路感染是常见的，导致了多药耐药生物的发展，药物相关的不良反应，以及巨大的成本。考虑到临床实践的现实，任何降低尿路感染发病率和死亡率的尝试都应包括预防菌尿和脓尿。先前的工作表明：1)在体外，小红莓成分可以减少细菌对尿路上皮细胞的黏附；2)小红莓汁对预防年轻人和老年人的尿路感染有效。 3)在疗养院居民中，使用蔓越莓胶囊是可行的，并且坚持使用，在短期监测期内不良事件最少。本研究的主要目的是测试每天两次口服小红莓胶囊预防女性养老院居民菌尿和脓尿的效果。这一目标将通过在康涅狄格州疗养院女性居民队列中进行一项双盲、随机、对照试验来实现，该试验对康涅狄格州一组女性养老院居民进行了为期12个月的每天两粒口服蔓越莓胶囊与安慰剂的对比试验。第二个目的是比较酸莓胶囊组和安慰剂组的尿路特异性症状的发生情况。这一目标将通过每次获取尿样时评估特定的尿路症状来实现。主要的假设是，与安慰剂相比，口服两粒小红莓胶囊将使12个月内菌尿和脓尿的发作相对减少33%。补充目标是确定：1)在12个月的监测期内每天服用蔓越橘胶囊的安全性；2)疗养院居民和工作人员遵守给药方案的情况；以及3)在12个月内使用蔓越莓和安慰剂的不良临床结果的发生率。活动的地点是康涅狄格州的10家养老院，参与者将从那里招募。参与者将是65岁及以上的女性长期护理养老院居民。主要结果将是菌尿和脓尿的存在，每两个月将通过清洁的尿液样本进行采样。尿路特殊症状的评估也将每两个月进行一次。检验基本假设的目标样本量是180名参与者，80%的力量，I型误差5%(双面)，在12个月的监测期内检测到菌尿和脓尿的相对减少33%。本研究的目的是确定小红莓胶囊是否能减少疗养院居民的菌尿和脓尿以及与尿路感染相关的症状。这项研究的影响是，小红莓胶囊可能被证明是一种可行的低风险干预措施，可以在这一脆弱人群中减少与尿路感染相关的不良临床结果。

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.