CompletedNot Applicable

Clinical Evaluation of Copesilcup

Chile256 participantsStarted 2024-01-01

Plain-language summary

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.

Who can participate

Age range

100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Catheter-Associated Urinary Tract Infection (CAUTI)

Timeframe: 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

Trial details

NCT IDNCT07530328

SponsorWMAS SpA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Catheter-Associated Infection trials