Urinary Tract Infection Clinical Trial
Official title:
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
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.
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. ;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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