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ISRCTN
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ISRCTN03525333
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ClinicalTrials.gov identifier
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Public title
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Development and randomised controlled trial of dipsticks and diagnostic algorithms for the management of urinary tract infection
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 97/14/06
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Study hypothesis
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1. To develop and test the use of different algorithms/symptom scores in the diagnosis of urinary tract infection (UTI)
2. To develop and test the use of different dipstick strategies in the diagnosis of UTI
3. To assess the cost effectiveness of common management strategies in the diagnosis and treatment of UTI
4. To assess the effect of the different strategies on patient satisfaction, beliefs and behaviour
Two phases: 1: Dipstick and score validation 2: Block randomised open trial of management strategies
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urinary tract infection
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Participants - inclusion criteria
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Subjects presenting with suspected urinary tract infections (UTI)
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Participants - exclusion criteria
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Pregnant women and women over the age of 75
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Anticipated start date
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10/09/2001
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Anticipated end date
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09/09/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Phase 1. Different symptom scores (naive Bayesian, adjusted Bayesian, symptom counts) and combinations of dipstick results will be developed to predict 'standard' monosodium urate (MSU) diagnosis in half the subjects (randomly chosen). The optimal strategies will be determined - from sensitivity, specificity, predictive values, likelihood ratios, and workload implications from the R.O. curves and tested with previous scores in the other half of the data.
Phase 2. This will be preceded by a development phase to determine the feasibility of trial procedures and exact strategy for each group derived from the results of phase 1. Patients will be block randomised to five groups:
a. Empiric antibiotic treatment (3 day course of trimethoprim)
b. Treatment based on algorithm/score (from phase 1)
c. Treatment based on dipstick (based on phase1)
d. Treatment based on positive MSU examination and culture
e. Control group (symptomatic treatment based on alkalinization of urine and other symptomatic measures)
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Primary outcome measure(s)
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Symptom diary, satisfaction, belief in antibiotics. Notes review for reattendance, complications, and referral. Costs: manual timing for GP and other staff costs; marginal costs in processing the MSUs.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Dr
Paul S
Little
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Address
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Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
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City/town
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Southampton
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Zip/Postcode
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SO16 5ST
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Country
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United Kingdom
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Tel
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+44 (0)2380 241062
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Fax
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+44 (0)2380 701125
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Email
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psl3@soton.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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10/01/2008
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Date ISRCTN assigned
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25/04/2003
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