Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: a pilot randomized clinical trial.
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.


CONCLUSIONS
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.
Department of Medicine, University of Minnesota, Minneapolis, MN. Electronic address: leuck002@umn.edu.
Anne-Marie
AM
Leuck
Department of Medicine, University of Minnesota, Minneapolis, MN; Department of Medicine, Veterans Affairs Healthcare System, Minneapolis, MN.
James R
JR
Johnson
Department of Neurosurgery, University of Minnesota, Minneapolis, MN.
Matthew A
MA
Hunt
Amarex Clinical Research, Germantown, MD.
Kush
K
Dhody
Amarex Clinical Research, Germantown, MD.
Kazem
K
Kazempour
Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN; Department of Pediatrics, University of Minnesota, Minneapolis, MN.
Patricia
P
Ferrieri
Department of Medicine, University of Minnesota, Minneapolis, MN.
Susan
S
Kline
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000494:pharmacology*; D001424:Bacterial Infections / Q000517:prevention & control*; D055499:Catheter-Related Infections / Q000517:prevention & control*; D020099:Coated Materials, Biocompatible; D005260:Female; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000517:prevention & control*; D010865:Pilot Projects; D012834:Silver / Q000009:adverse effects / Q000494:pharmacology*; D062885:Urinary Catheters; D014552:Urinary Tract Infections / Q000517:prevention & control*; D055815:Young Adult
D000890:Anti-Infective Agents; D020099:Coated Materials, Biocompatible; D012834:Silver
Catheter-associated bacteriuria; Foley catheter; Ionic silver; Urinary tract infection