A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 42
- 主要终点
- Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
研究概览
简要总结
Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female residents;
- •long term residents
- •English speaking; and
- •age ≥ 65 years.
排除标准
- •residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);
- •residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
- •residents with end stage renal disease on dialysis (they do not regularly produce urine);
- •residents unable to produce a baseline clean catch urine specimen for collection;
- •residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
- •residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
- •have an indwelling bladder catheter in place;
- •have an allergy to cranberry products;
- •are being treated with cranberry products;
- •residence <4 weeks.
结局指标
主要结局
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
时间窗: One year
Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
次要结局
- Number of Deaths(One year)
- Number of Antibiotic Prescriptions(One year)
- Number of Antibiotic Prescriptions for Suspected UTI(One Year)
- Number of Episodes of Symptomatic UTI(One year)
- Subjects With 1, 2, or 3 Episodes of UTIs(One year)
- Bacteriuria With Multidrug-resistant Gram-negative Bacilli(One year)
- Number of Hospitalizations(One year)