|- candidate number||3161|
|- NTR Number||NTR1266|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-apr-2008|
|- Secondary IDs||80-82310-98-08503 ZonMw doelmatigheid|
|- Public Title||The effects and costs of cranberry use to prevent symptomatic urinary tract intections in nursing home residents. |
|- Scientific Title||The effects and costs of cranberry use to prevent symptomatic urinary tract infections (UTI) in nursing home residents. |
|- Healt Condition(s) or Problem(s) studied||Urinary tract infections, Prevention, Cranberry|
|- Inclusion criteria||1. Age >= 65 jaar |
2. Life expectancy > 1 month
|- Exclusion criteria||1. Coumarine users |
2. Acute illness
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2008|
|- planned closingdate||1-feb-2011|
|- Target number of participants||1000|
|- Interventions||- Intervention (n=500): 2x dd Cranberry during 1 year.|
- Controles (n=500): 2x dd Placebo during 1 year.
|- Primary outcome||1. Time to first symtomatic UTI |
2. number of symptomatic UITs per included resident
3. Quality of life (EQ-5D)
4. Care dependency (Care dependency scale)
5. Resistence patterns of microbial agents
7. Side effects
8. Economic evaluation: cost effectivity analysis (cost per prevented UTI) and cost-utility analysis (costs per QUALY)
|- Secondary outcome||N/A|
|- Timepoints||At start study, after 6 and 12 months. |
During UTI 3 times a week for 3 weeks.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.A.A. Caljouw|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.A.A. Caljouw|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Public Health and Primary Care|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Springfield Nutraceuticals BV|
|- Brief summary||Objectives/research questions. |
To assess the effects and costs of cranberry use to prevent symptomatic UTIs in nursing home residents.
Double-blinded randomised placebo-controlled multi-centre intervention trial.
Study population and sample size.
All nursing home residents ≥ 65 years, except coumarin users, stratified by risk of symptomatic UTI (high versus low). The group with high risk of UTI includes nursing home residents with long-term catheterisation (> 1 month) and/or diabetes mellitus and/or a history of at least one treated symptomatic UTI in the preceding year.
To detect a 50% reduction in cumulative incidence of symptomatic UTIs, 1000 residents will be enrolled within a period of three months.
All nursing home residents ≥ 65 years and a life expectancy > 1 month are eligible, except those using coumarin.
Intervention: Cranberry capsule/sachet or placebo (both administered twice daily) during one year. The Cranberry capusule/sachet contains 1.8% proanthocyanidins (PACS)
The study does not interfere with standard care. Diagnostics and treatment will occur in accordance with current clinical guidelines.
• Effects: 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).
All data-analysis will be done on the basis of intention-to-treat analysis. Descriptive statistics, multivariate Cox-analyses and multivariate linear mixed models will be used.
M 1-7 preparation, M 8-10 inclusion of residents, M 8-22 intervention period, M 23-36 analyses and publication.
|- Main changes (audit trail)|
|- RECORD||1-apr-2008 - 16-jun-2008|