title: Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial.
abstract: BACKGROUND
  Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital. We aimed to establish whether short-term routine use of antimicrobial catheters reduced risk of CAUTI compared with standard polytetrafluoroethylene (PTFE) catheterisation.
  
  
  METHODS
  In our parallel, three group, multicentre, randomised controlled superiority trial, we enrolled adults (aged ≥16 years) requiring short-term (≤14 days) catheterisation at 24 hospitals in the UK. Participants were randomly allocated 1:1:1 with a remote computer allocation to receive a silver alloy-coated catheter, a nitrofural-impregnated catheter, or a PTFE-coated catheter (control group). Patients undergoing unplanned catheterisation were also included and consent for participation was obtained retrospectively. Participants and trial staff were unmasked to treatment assignment. Data were collected by trial staff and by patient-reported questionnaires for 6 weeks after randomisation. The primary outcome was incidence of symptomatic urinary tract infection for which an antibiotic was prescribed by 6 weeks. We postulated that a 3·3% absolute reduction in CAUTI would represent sufficient benefit to recommend routine use of antimicrobial catheters. This study is registered, number ISRCTN75198618.
  
  
  RESULTS
  708 (10%) of 7102 randomly allocated participants were not catheterised, did not confirm consent, or withdrew, and were not included in the primary analyses. Compared with 271 (12·6%) of 2144 participants in the control group, 263 (12·5%) of 2097 participants allocated a silver alloy catheter had the primary outcome (difference -0·1% [95% CI -2·4 to 2·2]), as did 228 (10·6%) of 2153 participants allocated a nitrofural catheter (-2·1% [-4·2 to 0·1]). Rates of catheter-related discomfort were higher in the nitrofural group than they were in the other groups.
  
  
  CONCLUSIONS
  Silver alloy-coated catheters were not effective for reduction of incidence of symptomatic CAUTI. The reduction we noted in CAUTI associated with nitrofural-impregnated catheters was less than that regarded as clinically important. Routine use of antimicrobial-impregnated catheters is not supported by this trial.
  
  
  BACKGROUND
  UK National Institute for Health Research Health Technology Assessment Programme.
authors.affiliation: Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK. robert.pickard@newcastle.ac.uk
authors.forename: Robert
authors.initials: R
authors.lastname: Pickard
authors.forename: Thomas
authors.initials: T
authors.lastname: Lam
authors.forename: Graeme
authors.initials: G
authors.lastname: MacLennan
authors.forename: Kath
authors.initials: K
authors.lastname: Starr
authors.forename: Mary
authors.initials: M
authors.lastname: Kilonzo
authors.forename: Gladys
authors.initials: G
authors.lastname: McPherson
authors.forename: Katie
authors.initials: K
authors.lastname: Gillies
authors.forename: Alison
authors.initials: A
authors.lastname: McDonald
authors.forename: Katherine
authors.initials: K
authors.lastname: Walton
authors.forename: Brian
authors.initials: B
authors.lastname: Buckley
authors.forename: Cathryn
authors.initials: C
authors.lastname: Glazener
authors.forename: Charles
authors.initials: C
authors.lastname: Boachie
authors.forename: Jennifer
authors.initials: J
authors.lastname: Burr
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.forename: Luke
authors.initials: L
authors.lastname: Vale
authors.forename: Adrian
authors.initials: A
authors.lastname: Grant
authors.forename: James
authors.initials: J
authors.lastname: N'Dow
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D055499:Catheter-Related Infections / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009583:Nitrofurazone / Q000008:administration & dosage*; D014546:Urinary Catheterization / Q000009:adverse effects*; D014552:Urinary Tract Infections / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D009583:Nitrofurazone