Foley catheter with noble metal alloy coating for preventing catheter-associated urinary tract infections: a large, multi-center clinical trial.

Catheter-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.

This 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.

The 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 ).

Antimicrobial resistance and infection control. 2021 Feb 25*** epublish ***

Ylva Kai-Larsen, Stefan Grass, Bhaumik Mody, Swati Upadhyay, Hargovind L Trivedi, Dilip K Pal, Santosh Babu, Bikash Bawari, Shrawan K Singh

Bactiguard AB, Alfred Nobels Allé 150, 146 48, Tullinge, Stockholm, Sweden. ., Bactiguard AB, Alfred Nobels Allé 150, 146 48, Tullinge, Stockholm, Sweden., Ethitrials Clinical Research Solution, Navrangpura, Ahmedabad, India., Apollo Hospitals International Limited, GIDC Estate, Bhat, India., Institute of Kidney Diseases and Research Centre (IKDRC), Institute of Transplantation Sciences (ITS), B. J. Medical College and Civil Hospital Campus, Ahmedabad, Gujarat, India., Institute of Post Graduate Medical Education and Research, Bose Road, Kolkata, India., Department of General Surgery, Gandhi Hospital, Musheerabad, Secunderabad, Telangana, India., Marwari Hospital and Research Centre S.J. Road, Athagaon, Assam, India., Department of Urology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

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