A Prospective Multicenter Randomized Study to Assess the Impact of a Novel Catheter Coating on Clinical Bacteriuria

Background: Catheter-associated urinary tract infections (CAUTIs) are a common source of morbidity and antibiotic use. Camstent Ltd. surface coated catheters aim to reduce bacterial colonization and infection. This study compares outcomes with Camstent Coated Catheters (CCC) versus standard uncoated catheters, Standard Care (SC). Objectives: The aim of the study was to investigate the reduction in bacteriuria in CCC versus SC, uncoated catheters. Methods: This is a prospective, UK, multi-center, randomized study including an Intention to Treat (ITT) population and a Per Protocol (PP) population of 200 and 188 subjects respectively. The PP population was sub-divided into primary and secondary cohorts with 107 and 81 subjects considered for study randomization receiving either a CCC or SC respectively. The primary endpoints including time to infection, number of days of infection and incidence of infection, and secondary endpoints including time to symptoms, UTI antibiotic use, patient reported outcomes like patient discomfort and catheter blockage were evaluated at days 0, 3, 5, 7, 10, 14, 21 and 28. For statistical analysis, Hodges-Lehmann and Fisher's exact test were used. Results: The primary end points: Colonization-free rates at day 7 were higher in the CCC group than in the SC group (79% versus 46%) and the difference persisted on day 14 (69% versus 39%) (p = 0.016); the mean number of days infected during the first 14 days was lower in the CCC group than the SC group (3 versus 4.6 days) (two-sided; p = 0.0117); the infection rates at day 14 were lower in the CCC group than SC group (33% versus 50%). This trend continued at days 21 and 28, with consistently lower infection rates in the CCC group than SC group but did not reach statistical significance (p > 0.05). The secondary endpoint is in the secondary cohort: Time to the development of symptoms defined as a UTI requiring antibiotics showed that zero cases occurred in the CCC compared with the SC group (0% versus 20%) at p = 0.0054; median time to symptoms in the SC group was 9.0 days; and expanding this endpoint to include the primary cohort revealed that symptomatic infections occurred at 4% in the CCC group and 20% in the SC group (p = 0.0007) with a longer median time to symptoms in the CCC group than SC (13.5 versus 7 days); UTI antibiotic use was significantly lower in the CCC group than the SC group (4% vs. 21%). Conclusions: Compared with SC, CCCs were associated with substantial reductions in bacterial colonization, symptomatic CAUTI, and antibiotic use, supporting their adoption within strategies to prevent CAUTIs and promote antimicrobial stewardship. Trial registration: This study was registered prospectively in the Clinical Trials Registry (NCT04461262; Study Details|NCT04461262|The Impact Of A Catheter Coating On Clinical Bacteriuria|r).