The Point Of carE testing for urinary Tract Infection in primary Care (POETIC) study: A randomised controlled trial of the clinical and cost effectiveness of Flexicult point of care urine culture.
The problem
Urinary tract infection (UTI) is the most frequent bacterial infection affecting women and accounts for about 15% of antibiotics prescribed in primary care. However, some women with symptoms suggestive of a UTI do not have a microbiologically confirmed UTI, and others are prescribed antibiotics to which the organism is resistant, or are not treated when they do have an infection. Inappropriate antibiotic prescribing unnecessarily increases risk of side effects, drives antibiotic resistance, and wastes resources.A simple culture test (FlexicultTM) that involves overnight incubation in a desktop incubator, based in a general practice surgery, may help primary care clinicians better target antibiotics (including giving antibiotics to the right women and giving the right antibiotic to women with an infection) for women with UTI.
The approach
POETIC (Point Of carE testing for urinary Tract Infection in primary Care) is a pragmatic, individually randomised controlled trial of women presenting with UTI symptoms in four primary care research networks (Wales, England, Spain, The Netherlands). Randomisation is to FlexicultTM-guided care or National guideline-informed ‘standard care'. Urine and stool samples are obtained at presentation (day 1) and at two weeks. Follow up on the course of illness, quality of life and costs is by completion of a symptom diary each day for two weeks. The primary outcome is appropriate (use of an antibiotic to which the cultured organism is sensitive if culture is positive, and no antibiotic if culture is negative) antibiotic use on day 3. Multi-level logistic regression will be used to produce odds ratios and associated 95% confidence intervals. Costs of the two management approaches will also be assessed in terms of the primary outcome.
Findings
642 (215 in Cardiff 231 in Southampton 161 in Spain and 35 in The Netherlands) adult women were randomised (324 to intervention and 318 to standard care). 265 in the Flexicult Arm and 275 in Standard Care were prescribed antibiotics at baseline. Primary outcome data is available for 521 patients. The results of this trial, including primary effectiveness and economic analyses, will be presented.
Consequences
FlexicultTM is already used routinely in some countries, however the clinical and cost effectiveness of such an approach has never been evaluated in a pragmatic randomised clinical trial. If shown to be effective, the use of this test could help provide more targeted antibiotic treatment, which is likely to benefit those experiencing UTI symptoms as well as reduce the selection pressure that has led to the widespread development of antibiotic resistance.
Credits
- Tim Pickles, Cochrane Institute of Primary Care and Public Health, Cardiff, UK
- Janine Bates, Cochrane Institute of Primary Care and Public Health, Cardiff, UK
- Emma Thomas-Jones, Cochrane Institute of Primary Care and Public Health, Cardiff, UK
- Nigel Kirby, Cochrane Institute of Primary Care and Public Health, Cardiff, UK
- Micaela Gal, Department of Primary Medical Care, Southampton, UK
- Emily Bongard, Department of Primary Medical Care, Southampton, UK
- Kerenza Hood, Cochrane Institute of Primary Care and Public Health, Cardiff, UK
- Nick Francis, Department of Primary Medical Care, Southampton, UK
- Paul Little, Primary Care Centre Jaume I, Tarragona, Spain
- Michael Moore, Primary Care Centre Jaume I, Tarragona, Spain
- Carlos Llor, Julius Centre for Health Sciences and Primary Care, Utrecht, The Netherlands
- Theo Verheij, Care Sciences Research Unit, Pontypridd, UK
- Mirella Longo, Specialist Anitmicrobial Chemotherapy Unit, Cardiff, UK
- Mandy Wootton
- Robin Howe
- Charles Cowtan, Cochrane Institute of Primary Care and Public Health, Cardiff, UK
- Mandy Lau, Cochrane Institute of Primary Care and Public Health, Cardiff, UK
- Christopher C Butler, Department of Primary Medical Care, Southampton, UK