Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: A pilot randomized clinical trial,
Published in American Journal of Infection Control, March 2015 Volume 43, Issue 3, Pages 260–265.Anne-Marie Leuck MD a,*, James R. Johnson MD a,b, Matthew A. Hunt MD c, Kush Dhody MBBS, MSc d, Kazem Kazempour PhD d, Patricia Ferrieri MD e, f, Susan Kline MD, MPH a
a) Department of Medicine, University of Minnesota, Minneapolis, MN
b) Department of Medicine, Veterans Affairs Healthcare System, Minneapolis, MN
c) Department of Neurosurgery, University of Minnesota, Minneapolis, MN
d) Amarex Clinical Research, Germantown, MD
e) Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN
f) Department of Pediatrics, University of Minnesota, Minneapolis, MN
Background: The purpose of this study was to evaluate the safety of a novel silver-impregnated Foley catheter system designed by ICET, Inc , 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. The control system was LUBRI-SIL I.C.antimicrobial silicone Foley catheter, Complete Care catheter system (CR Bard, Covington, GA) Time to ABU analysis compares ABU free population in the control and the test system
FDA IDE approval obtained now for a 300 subject pivotal trial based on the pilot study.