To assess the effects and costs of cranberry use to prevent symptomatic UTIs in nursing home residents.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•Effects study: time to first symptomatic UTI, number of symptomatic UTIs per
included resident, quality of life, care dependency, compliance, side effects,
medical consumption, resistance patterns of etiologic microbial agents, and
costs.
•The economic evaluation will include a cost-effectiveness analysis (costs per
prevented UTI) and a cost-utility analysis (costs per QALY).
Secondary outcome
N/A
Background summary
Symptomatic urinary tract infections (UTIs) are common in nursing homes
residents. The point prevalence of UTIs in nursing home residents is
approximately 3.8%. The incidence of UTIs varies from 44-58 per 100 residents
per year. The incidence of UTIs in nursing home residents is almost similar in
women and men (18-57% per year versus 19-38% per year.
Cranberry (Vaccinium macrocarpon) has been used to prevent symptomatic UTIs for
several decades. Cranberries contain proanthocyanidins; stable phenolic
compounds that exhibit potent anti-adhesion activity against E. coli and so
preventing attachment to uroepithelial cells and colonization of the urinary
tract. Recently, a double-blind placebo-controlled trial in older hospitalized
patients found a reduction of 50% of symptomatic UTIs in cranberry juice users.
A recent Cochrane review showed that there are ten international studies
evaluating the effect of cranberry products to prevent recurrent UTIs. There is
some evidence that cranberry juice may decrease the number of symptomatic UTIs
over a 12 month period, particularly for women with recurrent UTIs. It*s
effectiveness for elderly men and women are less clear and needs further
investigation. Daily cranberry use could be a possible candidate for the
prevention of UTIs in nursing home residents. However, despite of its shown
effectiveness, a major disadvantage of cranberry use is the costs of
prophylactic use. Further properly designed studies with relevant outcomes are
needed.
Symptomatic UTIs are among the most common clinical infections in nursing home
residents. Studying an intervention to prevent UTIs has high priority.
Study objective
To assess the effects and costs of cranberry use to prevent symptomatic UTIs in
nursing home residents.
Study design
Double-blinded randomised placebo-controlled multi-centre intervention trial.
Residents wil be stratified on symptomatic UTI risk (low and high risk).
The high UTI risk group includes residents with long-term catheterisation (> 1
month) and/or diabetes mellitus and/or having had at least one treated
symptomatic UTI in the preceding year. In both strata, eligible residents will
be randomised into an intervention group (n=500), receiving cranberry capsules
or sachets and into a placebo group (n=500), receiving a placebo capsule or
sachet twice a day. Residents will receive a capsule unless they can*t swallow
the capsule. These residents will receive a sachet. Randomisation will take
place on the level of residents.
Intervention
Two times a day one capsule of cranberry during one year.
Study burden and risks
In spite of being a natural product; there could be some side effects. It is
known that a high consumption of cranberry juice might cause nausea and
diarrhea. Also irritation of the stomach is possible. The placebo contains a
red colorant E122 (azorubine). This colorant could cause a hypersensitivity
reaction for people who are sensitive for salicylates, like asthma urticaria,
angio-oedema or hyperactive behaviour.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Age >= 65 years
Life expectancy > 1 month
Exclusion criteria
coumarine users
acute illness
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 3161 (kandidaat nummer trial register) |
CCMO | NL20654.058.08 |