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.
Urinary tract infection (UTI) is the most common infection in women living in nursing homes. Although cranberry juice has been shown to reduce bacteriuria plus pyuria in older women, most nursing home residents are unable to ingest the necessary quantity of juice required. This study will determine whether cranberry capsules, a low risk intervention, can reduce bacteriuria plus pyuria and the morbidity associated with UTI in this vulnerable population.
