跳至主要内容
临床试验/NCT00596635
NCT00596635已完成不适用

Cranberry for UTI Prevention in Residents of Long Term Care Facilities

Yale University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.

研究概览

简要总结

Urinary tract infections (UTIs) affect over 7 million men and women per year and cost the health care industry over 1 billion dollars annually. The incidence of UTI increases markedly in elderly institutionalized persons and leads to excessive antimicrobial usage, emergency room visits, hospitalization, sepsis, and death. The use of antimicrobials to prevent UTI in elderly nursing home patients is not recommended and is fraught with problems such as adverse reactions, drug interactions, and the development of drug-resistant organisms. There is no accepted method of preventing UTI in residents of nursing homes, a vulnerable and understudied population with significant morbidity from UTI.

The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for future larger studies.

详细描述

Cranberry products represent a novel, non-antimicrobial method for prevention of UTI. There is evidence for a plausible mechanism and efficacy for UTI prevention in healthy premenopausal women. Limited clinical studies of cranberry products in elderly men and women have demonstrated reductions in bacteriuria but have not been of adequate size or quality to support the use of cranberry in this population or result in changes in patient care. Thus, a properly designed, definitive study demonstrating efficacy of cranberry in preventing UTI in this population is needed. However, before a large-scale, placebo-controlled trial can be justified, the complexities inherent to studying older nursing home residents need to be addressed. These include issues related to collecting uncontaminated urine samples, understanding the microbiology of UTI in this population, and devising an acceptable intervention regimen. The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims listed below is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for a future RO1 level grant application.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Greater than 60 years old and a resident of the nursing home or assisted living facility for greater than 30 days duration

排除标准

  • Having a known major anatomic abnormality of the urinary tract
  • Presence of acute UTI symptom
  • Intolerance or allergy to cranberry products
  • Current use of cranberry for prevention of UTI
  • Use of warfarin
  • History of kidney stones
  • Presence of a chronic indwelling bladder catheter
  • Dialysis dependence
  • Chronic suppressive antibiotics
  • Immunocompromised state due to hematological malignancies, HIV infection, chronic high dose (>10mg daily) prednisone or equivalent steroid use.

结局指标

主要结局

Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.

时间窗: 6 months

Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.

次要结局

  • Number of Participants With E.Coli Isolated From Urine Culture(6 months)
  • Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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