Background: The purpose of this study was to evaluate the safety of a novel silver-impregnated Foley catheter system designed to prevent catheter-associated bacteriuria and funguria, assess recruitment feasibility for a future pivotal trial, and preliminarily assess efficacy. Methods: This single-center, randomized controlled trial at a university hospital involved adult neurosurgical patients expected to have a urinary catheter for ≥24 hours. Subjects were randomized to a novel silver-impregnated (test) Foley catheter system or a control system. They were followed for 30 days (or until discharge) while catheterized and for up to 48 hours after catheter removal, with daily bacteriuria testing and assessment for symptoms of infection and catheter intolerance. Results: Ninety-five subjects were randomized (intention-to-treat [ITT] population). Of these, 61 subjects (64%) had a catheter for ≥24 hours without perioperative antibiotics beyond 24 hours (evaluable population). In the ITT population, 11 of 95 (12%) subjects had an asymptomatic bacteriuria (ABU) event. Compared with controls, test system recipients had a trend toward longer time to ABU in the ITT population (P =.08, log-rank test) and a longer time to ABU in the evaluable population (P =.03). All 6 ABU events caused by gram-negative bacilli occurred in the control group. Conclusion: In this pilot randomized trial the test system was well tolerated and seemingly effective in preventing catheter-associated bacteriuria, especially with gram-negative bacilli. A pivotal study is warranted.
Bibliographical noteFunding Information:
Funding/support: This pilot study was supported by a small business innovation research grant awarded to ICET Inc by the National Institute of Diabetes and Digestive and Kidney Diseases (no. R44 DK55891-06). Leuck is supported by a National Institutes of Health Ruth L. Kirschstein National Research Service Award Institutional Research Training Grant (no. 5T32AI055433-09). This material is also based in part on work supported by the Department of Veterans Affairs ( Johnson , no. 1 I01 CX000192 01).
© 2015 Association for Professionals in Infection Control and Epidemiology, Inc.
- Catheter-associated bacteriuria
- Foley catheter
- Ionic silver
- Urinary tract infection