Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catherisation in hospital: A multicentre randomised controlled trial

Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK. Electronic address: .
The Lancet (Impact Factor: 45.22). 11/2012; 380(9857). DOI: 10.1016/S0140-6736(12)61380-4
Source: PubMed


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.

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Available from: Thomas B. L. Lam, Jun 02, 2014
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    • "However, the extreme heterogeneity of antimicrobials, processing technology and test methods makes the published reports difficult to compare with each other and with our very different processing and testing. Our duration data are also far in excess of those reported for commercially available antimicrobial catheters [11] [12] whose duration of activity is a few days at the most. Our previous studies on these two commercial catheters, silver-processed and nitrofural coated, showed a duration of activity of ≤ 2 days in the SPTT, and both failed the first challenge in the flow challenge test (data not shown), therefore validating the in vitro tests in respect of the clinical trial results. "
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    ABSTRACT: Catheter - associated urinary tract infection (CAUTI) is the commonest hospital - acquired infection, accounting for over 100,000 hospital admissions within the USA annually. Biomaterials and processes intended to reduce the risk of bacterial colonization of the catheters for long-term users have not been successful, mainly because of the need for long duration of activity in flow conditions. Here we report the results of impregnation of urinary catheters with a combination of rifampicin, sparfloxacin and triclosan. In flow experiments, the antimicrobial catheters were able to prevent colonization by common uropathogens Proteus mirabilis, Staphylococcus aureus and Escherichia coli for 7 to 12weeks in vitro compared with 1-3 days for other, commercially available antimicrobial catheters currently used clinically. Resistance development was minimized by careful choice of antimicrobial combinations. Drug release profiles and distribution in the polymer, and surface analysis were also carried out and the process had no deleterious effect on the mechanical performance of the catheter or its balloon. The antimicrobial catheter therefore offers for the first time a means of reducing infection and its complications in long-term urinary catheter users. Copyright © 2015. Published by Elsevier B.V.
    Journal of Controlled Release 01/2015; DOI:10.1016/j.jconrel.2015.01.037 · 7.71 Impact Factor
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    • "Urinary catheters represent such an infection risk that a number of antimicrobial catheters are available on the mass market. Although silver and nitrofural functionalized catheters were shown in a multicenter randomized clinical trial to offer little or no clinical benefit, at least for short-term (<14 days) catheterization,24 catheters coated with a CHX varnish have been reported,25–27 and the early laboratory and animal data are encouraging,28 showing a reduction in biofilm formation with the CHX-coated devices. "
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    ABSTRACT: Ethylene vinyl acetate (EVA) is in widespread use as a polymeric biomaterial with diverse applications such as intravitreal devices, catheters, artificial organs, and mouthguards. Many biomaterials are inherently prone to bacterial colonization, as the human body is host to a vast array of microbes. This can lead to infection at the biomaterial’s site of implantation or application. In this study, EVA was coated with chlorhexidine (CHX) hexametaphosphate (HMP) nanoparticles (NPs) precipitated using two different reagent concentrations: CHX-HMP-5 (5 mM CHX and HMP) and CHX-HMP-0.5 (0.5 mM CHX and HMP). Data gathered using dynamic light scattering, transmission electron microscopy, and atomic force microscopy indicated that the NPs were polydisperse, ~40–80 nm in diameter, and aggregated in solution to form clusters of ~140–200 nm and some much larger aggregates of 4–5 μM. CHX-HMP-5 formed large deposits on the polymer surface discernible using scanning electron microscopy, whereas CHX-HMP-0.5 did not. Soluble CHX was released by CHX-HMP-5 NP-coated surfaces over the experimental period of 56 days. CHX-HMP-5 NPs prevented growth of methicillin-resistant Staphylococcus aureus when applied to the polymer surfaces, and also inhibited or prevented growth of Pseudomonas aeruginosa with greater efficacy when the NP suspension was not rinsed from the polymer surface, providing a greater NP coverage. This approach may provide a useful means to treat medical devices fabricated from EVA to render them resistant to colonization by pathogenic microorganisms.
    International Journal of Nanomedicine 08/2014; 9(1):4145. DOI:10.2147/IJN.S65343 · 4.38 Impact Factor
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    • "A large randomized clinical trial assessing three different catheters (silver-alloy-coated, nitrofural-impregnated and a PTFE-coated catheters) in hospitalized adults with acute pathologies requiring short urinary catheterization has been recently published. No clinically relevant difference was noted between the three groups [6]. "
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    ABSTRACT: Patients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs. The study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients. The aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients.Trial registration: NCT01803919.
    BMC Urology 07/2013; 13(1):38. DOI:10.1186/1471-2490-13-38 · 1.41 Impact Factor
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