Leuck Anne-Marie, Johnson James R, Hunt Matthew A, Dhody Kush, Kazempour Kazem, Ferrieri Patricia, Kline Susan
Department of Medicine, University of Minnesota, Minneapolis, MN.
Department of Medicine, University of Minnesota, Minneapolis, MN; Department of Medicine, Veterans Affairs Healthcare System, Minneapolis, MN.
Am J Infect Control. 2015 Mar 1;43(3):260-5. doi: 10.1016/j.ajic.2014.11.021.
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.
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.
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.
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.
本研究的目的是评估一种新型含银Foley导尿管系统的安全性，该系统旨在预防导尿管相关的菌尿症和真菌尿症，评估未来关键试验的招募可行性，并初步评估疗效。
这项在大学医院进行的单中心随机对照试验纳入了预期留置导尿管≥24小时的成年神经外科患者。受试者被随机分配至新型含银（试验）Foley导尿管系统或对照系统。在留置导尿管期间对他们进行30天（或直至出院）的随访，并在拔除导尿管后长达48小时进行随访，每日进行菌尿症检测，并评估感染症状和导尿管不耐受情况。
95名受试者被随机分组（意向性分析[ITT]人群）。其中，61名受试者（64%）留置导尿管≥24小时，且术后24小时后未使用围手术期抗生素（可评估人群）。在ITT人群中，95名受试者中有11名（12%）发生无症状菌尿（ABU）事件。与对照组相比，试验系统接受者在ITT人群中发生ABU的时间有延长趋势（P = 0.08，对数秩检验），在可评估人群中发生ABU的时间更长（P = 0.03）。所有6例由革兰氏阴性杆菌引起的ABU事件均发生在对照组。
在这项初步随机试验中，试验系统耐受性良好，在预防导尿管相关菌尿症方面似乎有效，尤其是对革兰氏阴性杆菌。有必要开展一项关键研究。
