Bactiguard AB, Alfred Nobels Allé 150, 146 48, Tullinge, Stockholm, Sweden.
Ethitrials Clinical Research Solution, Navrangpura, Ahmedabad, India.
Antimicrob Resist Infect Control. 2021 Feb 25;10(1):40. doi: 10.1186/s13756-021-00907-w.
Catheter-associated urinary tract infections (CAUTI) are among the most frequent healthcare-associated infections in the world. They are associated with increased mortality, prolonged hospital stay and increased healthcare costs. The objective of this study was to evaluate the efficacy of the noble metal alloy (NMA) coated BIP Foley Catheter in preventing the incidence of symptomatic CAUTI in a large cohort of patients in India.
This multi-center, prospective study included 1000 adult patients admitted to six hospitals across India for urology, surgery and ICU requiring urethral catheterization and admission for ≥ 48 h. Patients were allocated to the NMA-coated BIP Foley Catheter group or a non-coated control catheter group, with a randomization ratio of 3:1. CAUTI surveillance was conducted at study entry, upon catheter removal, and 2 days after catheter removal. For statistical analysis, categorical data (e.g. gender) were compared using the chi-square or Fischer test, and numerical data were compared using the two-sample t-test. Associations were evaluated using logistic regression.
The incidence of symptomatic CAUTI was reduced by 69% in the BIP Foley Catheter group compared to the control group (6.5 vs 20.8 CAUTI/1000 catheter days), with an incidence rate ratio of 0.31 (95% confidence interval: 0.21-0.46; p < 0.001). A reduction in the cumulative CAUTI incidence was evident in the BIP Foley Catheter group within 3 days after catheterization; this reduction was maintained up to ~ 30 days, and the largest reductions were seen between 3 and 11 days. There were no serious adverse events related to either catheter, and the percentage of patients with ≥ 1 adverse event was significantly lower in the NMA-coated BIP Foley Catheter group than in the control group (21.6% vs. 48.4%; p = 0.001). In conclusion, the NMA-coated BIP Foley Catheter was effective in reducing CAUTI and was well tolerated, with a lower incidence of adverse events compared to the uncoated catheter. Trial registration This study was registered prospectively (28 September 2015) in the Clinical Trials Registry of India (trial number CTRI/2015/09/006220; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=12631&EncHid=&userName=bactiguard ).
导管相关尿路感染（CAUTI）是全球最常见的医疗相关感染之一。它们与死亡率增加、住院时间延长和医疗保健费用增加有关。本研究的目的是评估在印度的一个大患者队列中，使用贵金属合金（NMA）涂层 BIP Foley 导尿管预防有症状 CAUTI 发生率的疗效。
这是一项多中心、前瞻性研究，纳入了 1000 名因泌尿科、外科和 ICU 住院需要导尿且住院时间≥48 小时的成年患者。患者被分配到 NMA 涂层 BIP Foley 导尿管组或非涂层对照导尿管组，随机分配比例为 3:1。在研究开始时、导管拔出时和导管拔出后 2 天进行 CAUTI 监测。对于统计分析，使用卡方或 Fischer 检验比较分类数据（例如性别），使用两样本 t 检验比较数值数据。使用逻辑回归评估关联。
与对照组相比，BIP Foley 导尿管组有症状 CAUTI 的发生率降低了 69%（6.5 例/1000 导管日比 20.8 例/1000 导管日），发生率比为 0.31（95%置信区间：0.21-0.46；p<0.001）。在导管插入后 3 天内，BIP Foley 导尿管组的累积 CAUTI 发生率明显降低；这种降低一直持续到约 30 天，并且在 3 至 11 天之间观察到最大的降低。两种导管均无严重不良事件，NMA 涂层 BIP Foley 导尿管组发生≥1 次不良事件的患者比例明显低于对照组（21.6%比 48.4%；p=0.001）。总之，与未涂层导尿管相比，NMA 涂层 BIP Foley 导尿管可有效降低 CAUTI 发生率，且耐受性良好，不良事件发生率较低。
本研究在印度临床试验注册处（试验编号 CTRI/2015/09/006220；http://ctri.nic.in/Clinicaltrials/showallp.php？mid1=12631&EncHid=&userName=bactiguard ）进行了前瞻性注册（2015 年 9 月 28 日）。
