Cranberry Capsules for Prevention of UTI in Nursing Home Residents

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%的人也有脓尿，细菌尿的抗生素治疗并没有降低发病率或死亡率。鉴别细菌尿与症状性尿路感染充满了临床诊断挑战。因此，对于假定的尿路感染，抗生素治疗是常见的，导致多药抗生素耐药生物的发展，药物相关的不良反应和巨大的成本。鉴于临床实践的现实，任何降低尿路感染发病率和死亡率的尝试都应该包括预防细菌尿和脓尿。先前的研究表明：1)蔓越莓成分在体外可减少细菌对尿上皮细胞的粘附；2)蔓越莓汁对年轻人和老年人预防尿路感染都有效

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.