Clinical Evaluation of the Efficacy and Safety of a Long-Term Urinary Catheter Made of PEGylated Silicone With Copper Nanoparticles for the Reduction of Urinary Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Incidence of Catheter-Associated Urinary Tract Infection (CAUTI)
研究概览
简要总结
Healthcare-associated infections (HAIs): HAIs are a problem for all institutions and countries worldwide. Currently, one of the main infections is catheter-associated urinary tract infection (CAUTI). Problem: Infection associated with permanent urinary catheters is a problem with a significant social and public health impact due to its high morbidity, mortality, and associated costs. The COPESIL technology developed in the FONDEF ID19I10113 project consists of the modification and functionalization of silicone materials through the anchoring of polyethylene glycol molecules on their surface (pegylation process). Our technology showed significant antimicrobial and anti-biofilm capacity in in vitro and in vivo models. This proposal aims to scale up COPESIL technology to a permanent urinary catheter that we have named COPESILCUP. The creation of a new device and its clinical validation will open up and revolutionize research in biomaterials. State of the art: Currently, there are a variety of urinary catheters designed to reduce the risk of infection. These include catheters impregnated with antibiotics (nitrofurantoin, minocycline, and rifampicin), silver oxide, and silver alloys. However, these catheters have little effect on the adhesion of uropathogens. The hypothesis is proposed: The use of a permanent silicone urinary catheter modified through a pegylation process that incorporates copper nanoparticles (COPESILCUP), which has antimicrobial and anti-biofilm properties, reduces the incidence of urinary tract infection in hospitalized adults who use permanent urinary catheters compared to unmodified silicone urinary catheters. The overall objective of this project is to develop a permanent silicone urinary catheter modified through a pegylation process that incorporates copper nanoparticles (COPESILCUP), which has antimicrobial and anti-biofilm properties, and to evaluate its efficacy by measuring the incidence of urinary tract infections and its safety in humans using permanent urinary catheters in a public hospital for adults. Methodology: Clinical validation of COPESILCUP in a Randomized Controlled Clinical Trial: the aim is to validate the medical device in a real patient setting in order to establish whether it is better than the standard.
详细描述
Catheter-associated urinary tract infections (CAUTIs) are among the most common healthcare-associated infections worldwide and represent a significant burden in terms of morbidity, mortality, healthcare costs, and antimicrobial use. The risk of infection increases with the duration of catheterization and is particularly relevant in hospitalized patients and those requiring prolonged use of indwelling urinary catheters.
The pathophysiology of CAUTIs is strongly associated with the rapid formation of bacterial biofilm on the catheter surface, a process that can begin within hours to days after device insertion. Biofilm provides a protective environment for microorganisms, facilitating persistence, reducing susceptibility to antimicrobial therapy, and enabling evasion of host immune responses. Once established, biofilm contributes to recurrent infections and increases the risk of severe clinical complications.
Current preventive strategies include antimicrobial-impregnated catheters and devices coated with metals such as silver. However, these approaches have shown limited effectiveness in preventing early bacterial adhesion and biofilm formation, and may raise concerns regarding durability of effect and potential contribution to antimicrobial resistance.
COPESILCUP is an investigational medical device consisting of a medical-grade silicone urinary catheter modified through a surface functionalization strategy that incorporates copper-based structures. Copper is a well-known broad-spectrum antimicrobial element, capable of disrupting bacterial cell membranes, inducing oxidative stress, and interfering with essential microbial metabolic processes.
In this device, copper is integrated as part of the surface modification of the material, with the objective of reducing bacterial adhesion and interfering with early stages of biofilm formation. This approach targets the material-microorganism interface and aims to maintain the mechanical and functional properties of conventional silicone catheters, without relying on sustained release of antimicrobial agents into the surrounding environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking Description
This study is triple-blinded. Study participants, healthcare providers responsible for catheter insertion and clinical care, and outcome assessors are blinded to treatment allocation.
The investigational device (COPESILCUP) and the control device (standard silicone urinary catheter) are visually indistinguishable and are packaged and labeled using coded identifiers. Randomization codes are generated and maintained by personnel not involved in patient care, outcome assessment, or data analysis.
Blinding is maintained throughout the study period until completion of data collection and primary analyses. Unblinding is permitted only in the event of a serious adverse event when knowledge of the assigned device is necessary for patient safety.
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥18 years of age).
- •Hospitalized patients from medical, surgical, emergency, operating room, or intensive care units.
- •Patients with clinical indication for permanent urinary catheterization (Catéter Urinario Permanente, CUP).
- •Patients able to provide written informed consent, or consent provided by a legally authorized representative.
排除标准
- •History of urinary tract infection prior to hospitalization within the last month without a post-treatment follow-up urine culture.
- •Patients with a positive initial urine culture at the time of permanent urinary catheter (CUP) insertion.
- •Patients with a history of allergy to silicone or to any component of the COPESILCUP device.
- •Patients unable to complete follow-up, for example, due to transfer to another healthcare facility within the first 72 hours after stabilization.
- •Patients with psychiatric conditions that may result in non-professional manipulation of the urinary catheter.
- •Patients with a history of prior urinary tract colonization.
- •Patients with a history of urinary or renal instrumentation or surgical intervention within the last month.
- •Patients with pre-existing abnormalities of the pyeloureteral or urinary system.
研究组 & 干预措施
COPESILCUP Urinary Catheter
Participants assigned to this group receive an indwelling urinary catheter made of medical-grade silicone with surface modification incorporating copper-based nanoparticles (COPESILCUP). The catheter is inserted and managed according to standard clinical practice for urinary catheterization.
干预措施: PEGylated Silicone Urinary Catheter with Copper Nanoparticles (COPESILCUP) (Device)
Standard Silicone Urinary Catheter
Participants assigned to this group receive a standard indwelling urinary catheter made of medical-grade silicone without surface modification. The catheter is inserted and managed according to routine clinical practice.
干预措施: Control Device (Device)
结局指标
主要结局
Incidence of Catheter-Associated Urinary Tract Infection (CAUTI)
时间窗: At Day 1 (baseline), Day 7, Day 14, Day 21, and Day 28 (up to 30 days) of follow-up or until catheter removal, whichever occurs first
Incidence of catheter-associated urinary tract infection, defined as the presence of a positive urine culture combined with clinical and/or laboratory findings consistent with urinary tract infection, assessed during the period of permanent urinary catheter use.
次要结局
- Time to First Positive Urine Culture(At Day 1 (baseline), Day 7, Day 14, Day 21, and Day 28 (up to 30 days).)
- Relative Risk of Catheter-Associated Urinary Tract Infection(At Day 1 (baseline), Day 7, Day 14, Day 21, and Day 28 (up to 30 days).)
- Incidence of Device-Related Adverse Events(From Day 1 (catheter insertion) up to 30 days or until catheter removal, whichever occurs first)
研究者
María Cristina Paredes Escobar
PhD in Public Health
WMAS SpA