Urinary Tract Infection
Conditions
Keywords
UTI, elderly, prevention, cranberry, E.Coli
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.
Interventions
DIETARY_SUPPLEMENTOnce Daily Cranberry Capsule
650mg capsule pure cranberry powder
DIETARY_SUPPLEMENTTwice Daily Cranberry Capsules
One 650mg cranberry capsule administered twice per day
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With E.Coli Isolated From Urine Culture | 6 months | Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome. |
| Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture | 6 months | Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had \>100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome. |
Countries
United States
Participant flow
Recruitment details
Four dementia units participated in this study. Exclusion criteria included: 1)indwelling catheter, 2)residence \<4 weeks, 3)prednisone therapy, 4)active UTI symptoms, 5)terminal, 6)end stage renal disease, 7)\<60 years old, 8)chronic suppressive antibiotic therapy, 9)history of kidney stones, 10)unable to provide baseline urine, 11)warfarin therapy.
Pre-assignment details
If a participant could not provide a baseline urine specimen or met an exclusion criterion prior to group assignment but after consent, he or she was not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| No Cranberry Capsules Control Group No Cranberry Capsule | 17 |
| One Cranberry Capsule 1 650mg cranberry capsule daily | 20 |
| 2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid) | 19 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Could not provide urine specimen | 1 | 2 | 2 |
| Overall Study | Hip fracture | 2 | 3 | 3 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
| Overall Study | Treatment for symptomatic UTI | 4 | 6 | 3 |
Baseline characteristics
| Characteristic | One Cranberry Capsule | 2 Cranberry Capsules | No Cranberry Capsules | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 19 Participants | 16 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age Continuous | 88.30 years STANDARD_DEVIATION 6.16 | 86.68 years STANDARD_DEVIATION 5.16 | 85.76 years STANDARD_DEVIATION 11.76 | 86.82 years STANDARD_DEVIATION 7.97 |
| Region of Enrollment United States | 20 participants | 19 participants | 17 participants | 56 participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 13 Participants | 46 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 17 | 5 / 20 | 3 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 | 0 / 19 |
Outcome results
Primary
Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Cranberry Capsules | Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. | Number of urine cultures expected | 81 Urine cultures |
| No Cranberry Capsules | Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. | Number of urine cultures collected | 73 Urine cultures |
| One Cranberry Capsule | Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. | Number of urine cultures expected | 74 Urine cultures |
| One Cranberry Capsule | Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. | Number of urine cultures collected | 63 Urine cultures |
| 2 Cranberry Capsules | Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. | Number of urine cultures expected | 85 Urine cultures |
| 2 Cranberry Capsules | Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. | Number of urine cultures collected | 71 Urine cultures |
Secondary
Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture
Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had \>100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Cranberry Capsules | Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture | 12 Participants |
| One Cranberry Capsule | Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture | 13 Participants |
| 2 Cranberry Capsules | Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture | 14 Participants |
Secondary
Number of Participants With E.Coli Isolated From Urine Culture
Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Cranberry Capsules | Number of Participants With E.Coli Isolated From Urine Culture | 8 Participants |
| One Cranberry Capsule | Number of Participants With E.Coli Isolated From Urine Culture | 8 Participants |
| 2 Cranberry Capsules | Number of Participants With E.Coli Isolated From Urine Culture | 12 Participants |