N/A
N=56
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT00596635 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. — 81; 74; 85; 73 Urine cultures
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Once Daily Cranberry Capsule (Dietary_supplement); Twice Daily Cranberry Capsules (Dietary_supplement)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. |
81; 74; 85; 73; 63; 71 | — |
| SECONDARY Number of Participants With E.Coli Isolated From Urine Culture |
8; 8; 12 | — |
| SECONDARY Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture |
12; 13; 14 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00596635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.