Contact information
Type
Scientific
Primary contact
Dr Paul S Little
ORCID ID
Contact details
Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1062
psl3@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 97/14/06
Study information
Scientific title
Acronym
Study hypothesis
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
More details can be found at: http://www.hta.ac.uk/1205
Protocol can be found at: http://www.hta.ac.uk/protocols/199700140006.pdf
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Urinary tract infection
Intervention
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:
1. Empiric antibiotic treatment (3 day course of trimethoprim)
2. Treatment based on algorithm/score (from phase 1)
3. Treatment based on dipstick (based on phase 1)
4. Treatment based on positive MSU examination and culture
5. Control group (symptomatic treatment based on alkalinization of urine and other symptomatic measures)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Symptom diary
2. Satisfaction
3. Belief in antibiotics
4. Notes review for
4.1. reattendance
4.2. complications
4.3. referral
5. Costs
5.1. manual timing for GP and other staff costs
5.2. marginal costs in processing the MSUs
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/09/2001
Overall trial end date
09/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Subjects presenting with suspected urinary tract infections (UTI)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
309 (added 09/02/10; see publication)
Participant exclusion criteria
Pregnant women and women over the age of 75
Recruitment start date
10/09/2001
Recruitment end date
09/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16882379
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20139214
3. 2010 cost effectiveness analysis in http://www.ncbi.nlm.nih.gov/pubmed/20139218
Publication citations
-
Results
Little P, Moore MV, Turner S, Rumsby K, Warner G, Lowes JA, Smith H, Hawke C, Leydon G, Arscott A, Turner D, Mullee M, Effectiveness of five different approaches in management of urinary tract infection: randomised controlled trial., BMJ, 2010, 340, c199.
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Cost effectiveness analysis
Turner D, Little P, Raftery J, Turner S, Smith H, Rumsby K, Mullee M, , Cost effectiveness of management strategies for urinary tract infections: results from randomised controlled trial., BMJ, 2010, 340, c346.
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Little P, Turner S, Rumsby K, Warner G, Moore M, Lowes JA, Smith H, Hawke C, Mullee M, Developing clinical rules to predict urinary tract infection in primary care settings: sensitivity and specificity of near patient tests (dipsticks) and clinical scores., Br J Gen Pract, 2006, 56, 529, 606-612.