Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
555555
Study information
Scientific title
Acronym
Study hypothesis
1. What is the relative effectiveness of low dose trimethoprim compared to cranberry product in the prevention of urinary tract infections in older women with recurrent infections?
2. What is the acceptability of and adherence to both preventative treatments?
Ethics approval
Approval granted by the Tayside Committee of Medical Research Ethics on 23rd March 2006 (ref: 06/S1402/23)
Study design
Double-blind, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Recurrent urinary tract infections
Intervention
Trimethoprim 100 mg daily versus 500 mg cranberry product daily
Intervention type
Drug
Phase
Not Specified
Drug names
Trimethoprim
Primary outcome measures
First recurrence of symptomatic urinary tract infection
Secondary outcome measures
Acceptability and adherence
Overall trial start date
01/09/2006
Overall trial end date
31/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Community dwelling women aged 45 years or over with at least two antibiotic-treated urinary tract infections or episodes of cystitis in the previous 12 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Previous urological surgery, stone or anatomical abnormalities
2. Urinary catheter
3. Diabetes mellitus
4. Immunocompromised
5. Pyelonephritis
6. Severe renal impairment
7. Blood dyscrasia
8. Symptomatic urinary tract infection (UTI) at baseline
9. Cognitive impairment precluding informed consent
10. Resident in institutional care
11. On longterm antibiotics
12. On warfarin therapy
13. Regular cranberry consumers
14. Unwilling to participate
Recruitment start date
01/09/2006
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ageing and Health
Dundee
DD1 9SY
United Kingdom
Funders
Funder type
Charity
Funder name
Moulton Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19042940
Publication citations
-
Results
McMurdo ME, Argo I, Phillips G, Daly F, Davey P, Cranberry or trimethoprim for the prevention of recurrent urinary tract infections? A randomized controlled trial in older women., J. Antimicrob. Chemother., 2009, 63, 2, 389-395, doi: 10.1093/jac/dkn489.