Giuseppe
Emeritus
[Source: The Lancet Infectious Diseases, full text: (LINK). Abstract, edited.]
------
The Lancet, Early Online Publication, 5 November 2012
doi:10.1016/S0140-6736(12)61380-4
Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial
Original Text
Prof Robert Pickard MD a ?, Thomas Lam PhD b ?, Graeme MacLennan MSc c, Kath Starr BSc b e, Mary Kilonzo MSc d, Gladys McPherson PhD e, Katie Gillies PhD c, Alison McDonald MSc e, Katherine Walton FRCPath f, Brian Buckley PhD g h, Prof Cathryn Glazener PhD c, Charles Boachie MSc c, Jennifer Burr MSc e, Prof John Norrie MSc e, Prof Luke Vale PhD i, Prof Adrian Grant DM j, Prof James N'Dow MD b
Summary
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.
Findings
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.
Interpretation
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.
Funding
UK National Institute for Health Research Health Technology Assessment Programme.
___________________________
a Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK; b Academic Urology Unit, University of Aberdeen, Aberdeen, UK; c Health Services Research Unit, University of Aberdeen, Aberdeen, UK; d Health Economics Research Unit, University of Aberdeen, Aberdeen, UK; e Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK; f Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; g Department of General Practice, National University of Ireland, Galway, Ireland; h College of Medicine, University of the Philippines, Manila; i Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK; j Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
Correspondence to: Prof Robert Pickard, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne NE2 4HH, UK
? Authors contributed equally
-doi:10.1016/S0140-6736(12)61380-4
Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial
Original Text
Prof Robert Pickard MD a ?, Thomas Lam PhD b ?, Graeme MacLennan MSc c, Kath Starr BSc b e, Mary Kilonzo MSc d, Gladys McPherson PhD e, Katie Gillies PhD c, Alison McDonald MSc e, Katherine Walton FRCPath f, Brian Buckley PhD g h, Prof Cathryn Glazener PhD c, Charles Boachie MSc c, Jennifer Burr MSc e, Prof John Norrie MSc e, Prof Luke Vale PhD i, Prof Adrian Grant DM j, Prof James N'Dow MD b
Summary
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.
Findings
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.
Interpretation
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.
Funding
UK National Institute for Health Research Health Technology Assessment Programme.
___________________________
a Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK; b Academic Urology Unit, University of Aberdeen, Aberdeen, UK; c Health Services Research Unit, University of Aberdeen, Aberdeen, UK; d Health Economics Research Unit, University of Aberdeen, Aberdeen, UK; e Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK; f Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; g Department of General Practice, National University of Ireland, Galway, Ireland; h College of Medicine, University of the Philippines, Manila; i Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK; j Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
Correspondence to: Prof Robert Pickard, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne NE2 4HH, UK
? Authors contributed equally
------