Abstract
BackgroundCatheter-associated urinary tract infections (CAUTI) are among the most frequent healthcare-associated infections in the world. They are associated with increased mortality, prolonged hospital stay and increased healthcare costs. The objective of this study was to evaluate the efficacy of the noble metal alloy (NMA) coated BIP Foley Catheter in preventing the incidence of symptomatic CAUTI in a large cohort of patients in India.MethodsThis multi-center, prospective study included 1000 adult patients admitted to six hospitals across India for urology, surgery and ICU requiring urethral catheterization and admission for ≥ 48 h. Patients were allocated to the NMA-coated BIP Foley Catheter group or a non-coated control catheter group, with a randomization ratio of 3:1. CAUTI surveillance was conducted at study entry, upon catheter removal, and 2 days after catheter removal. For statistical analysis, categorical data (e.g. gender) were compared using the chi-square or Fischer test, and numerical data were compared using the two-sample t-test. Associations were evaluated using logistic regression.Results and conclusionsThe incidence of symptomatic CAUTI was reduced by 69% in the BIP Foley Catheter group compared to the control group (6.5 vs 20.8 CAUTI/1000 catheter days), with an incidence rate ratio of 0.31 (95% confidence interval: 0.21–0.46; p < 0.001). A reduction in the cumulative CAUTI incidence was evident in the BIP Foley Catheter group within 3 days after catheterization; this reduction was maintained up to ~ 30 days, and the largest reductions were seen between 3 and 11 days. There were no serious adverse events related to either catheter, and the percentage of patients with ≥ 1 adverse event was significantly lower in the NMA-coated BIP Foley Catheter group than in the control group (21.6% vs. 48.4%; p = 0.001). In conclusion, the NMA-coated BIP Foley Catheter was effective in reducing CAUTI and was well tolerated, with a lower incidence of adverse events compared to the uncoated catheter.Trial registration This study was registered prospectively (28 September 2015) in the Clinical Trials Registry of India (trial number CTRI/2015/09/006220; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=12631&EncHid=&userName=bactiguard).
Highlights
Healthcare-associated infections (HAI) are common and represent a significant global burden of disease, with increased mortality, prolonged hospital stay and increased healthcare costs [1,2,3]
Patients were enrolled between December 2015 and April 2018; 750 were randomized to receive the Bactiguard infection protection (BIP) Foley Catheter and 250 were allocated to the control group
Nine hundred and one patients completed the study per protocol, and 99 patients (71 in the BIP Foley Catheter group and 28 in the control group) were withdrawn early (Fig. 3)
Summary
Healthcare-associated infections (HAI) are common and represent a significant global burden of disease, with increased mortality, prolonged hospital stay and increased healthcare costs [1,2,3]. Since urinary catheters are the most commonly used medical device in the world, catheter-associated urinary tract infections (CAUTI) are among the most frequent HAI, with more than 150 million cases/year [4]. Patients with CAUTI have prolonged hospital stays and additional costs ranging between $876 and $10,197 are incurred [5,6,7]. Catheter-associated urinary tract infections (CAUTI) are among the most frequent healthcare-asso‐ ciated infections in the world. They are associated with increased mortality, prolonged hospital stay and increased healthcare costs. The objective of this study was to evaluate the efficacy of the noble metal alloy (NMA) coated BIP Foley Catheter in preventing the incidence of symptomatic CAUTI in a large cohort of patients in India
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