Clinical trial NCT00596635: Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Official title: Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: UTI
elderly
prevention
cranberry
E.Coli
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 56
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With E.Coli Isolated From Urine Culture
timeFrame: 6 months
measure: Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Assistant Professor
name: Manisha Juthani-Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juthani-Mehta M, Perley L, Chen S, Dziura J, Gupta K. Feasibility of cranberry capsule administration and clean-catch urine collection in long-term care residents. J Am Geriatr Soc. 2010 Oct;58(10):2028-30. doi: 10.1111/j.1532-5415.2010.03080.x. No abstract available.