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 ).

中文翻译：

---

带有贵金属合金涂层的 Foley 导管，用于预防导管相关性尿路感染：一项大型多中心临床试验

导管相关尿路感染 (CAUTI) 是世界上最常见的医疗保健相关感染之一。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贵金属合金 (NMA) 涂层的 BIP Foley 导管在印度大量患者中预防症状性 CAUTI 发生率的功效。这项多中心、前瞻性研究包括 1000 名在印度六家医院收治的泌尿外科、外科和 ICU 需要导尿和住院时间≥48 小时的成年患者。患者被分配到 NMA 涂层 BIP Foley 导管组或非涂层对照组，随机比例为 3:1。CAUTI 监测是在研究进入时、导管移除后进行的，和导管拔除后 2 天。对于统计分析，分类数据（例如性别）使用卡方检验或 Fischer 检验进行比较，数值数据使用双样本 t 检验进行比较。使用逻辑回归评估关联。与对照组相比，BIP Foley 导管组症状性 CAUTI 的发生率降低了 69%（6.5 对 20.8 CAUTI/1000 导管天），发生率为 0.31（95% 置信区间：0.21-0.46；p < 0.001)。BIP Foley 导管组在导管插入后 3 天内累积 CAUTI 发生率明显降低；这种减少持续了大约 30 天，最大的减少出现在 3 到 11 天之间。没有与任一导管相关的严重不良事件，NMA 涂层 BIP Foley 导管组发生≥1 次不良事件的患者百分比显着低于对照组（21.6% 对 48.4%；p = 0.001）。总之，NMA 涂层 BIP Foley 导管可有效减少 CAUTI，耐受性良好，与未涂层导管相比，不良事件发生率较低。试验注册 本研究在印度临床试验注册处前瞻性注册（2015 年 9 月 28 日）（试验编号 CTRI/2015/09/006220；http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=12631&EncHid= &userName=bactiguard )。与未涂层导管相比，不良事件的发生率较低。试验注册 本研究在印度临床试验注册处前瞻性注册（2015 年 9 月 28 日）（试验编号 CTRI/2015/09/006220；http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=12631&EncHid= &userName=bactiguard )。与未涂层导管相比，不良事件的发生率较低。试验注册 本研究在印度临床试验注册处前瞻性注册（2015 年 9 月 28 日）（试验编号 CTRI/2015/09/006220；http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=12631&EncHid= &userName=bactiguard )。