title: Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT™ informed management of uncomplicated UTI in primary care.
abstract: BACKGROUND
  Urinary tract infections (UTI) are the most frequent bacterial infection affecting women and account for about 15% of antibiotics prescribed in primary care. However, some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics, while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics. Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance, and wastes resources.
  
  
  METHODS
  614 adult female patients will be recruited from four primary care research networks (Wales, England, Spain, the Netherlands) and individually randomised to either POCT guided care or the guideline-informed 'standard care' arm. Urine and stool samples (where possible) will be obtained at presentation (day 1) and two weeks later for microbiological analysis. All participants will be followed up on the course of their illness and their quality of life, using a 2 week self-completed symptom diary. At 3 months, a primary care notes review will be conducted for evidence of further evidence of treatment failures, recurrence, complications, hospitalisations and health service costs.
  
  
  CONCLUSIONS
  Although the Flexicult™ POCT is used in some countries in routine primary care, it's clinical and cost effectiveness has never been evaluated in a randomised clinical trial. If shown to be effective, the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe.
  
  
  BACKGROUND
  ISRCTN65200697 (Registered 10 September 2013).
authors.forename: Janine
authors.initials: J
authors.lastname: Bates
authors.forename: Emma
authors.initials: E
authors.lastname: Thomas-Jones
authors.forename: Timothy
authors.initials: T
authors.lastname: Pickles
authors.forename: Nigel
authors.initials: N
authors.lastname: Kirby
authors.forename: Micaela
authors.initials: M
authors.lastname: Gal
authors.forename: Emily
authors.initials: E
authors.lastname: Bongard
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
authors.forename: Nicolas
authors.initials: N
authors.lastname: Francis
authors.forename: Paul
authors.initials: P
authors.lastname: Little
authors.forename: Michael
authors.initials: M
authors.lastname: Moore
authors.forename: Kate
authors.initials: K
authors.lastname: Rumsby
authors.forename: Carlos
authors.initials: C
authors.lastname: Llor
authors.forename: Curt
authors.initials: C
authors.lastname: Burgman
authors.forename: Theo
authors.initials: T
authors.lastname: Verheij
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.forename: Mandy
authors.initials: M
authors.lastname: Wootton
authors.forename: Robin
authors.initials: R
authors.lastname: Howe
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Butler
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D046508:Culture Techniques; D019468:Disease Management; D005260:Female; D006801:Humans; D008826:Microbial Sensitivity Tests; D019095:Point-of-Care Systems; D011320:Primary Health Care; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000175:diagnosis* / Q000188:drug therapy; D014556:Urine / Q000382:microbiology*
chemical_list: D000900:Anti-Bacterial Agents