Copper Use as Protection Against Antimicrobial Resistance in the ICU (CUPRIC)

January 18, 2023 updated by: Jose M Munita, Universidad del Desarrollo
CUPRIC is an investigator initiated and conducted, prospective, quasi-experimental study to determine whether the combined use of copper-alloyed objects plus copper-enriched textiles reduce the burden of MDRO colonization and HAIs incidence in the critically ill population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: Healthcare-associated infections (HAI) are among the leading causes of preventable death and are associated with significant financial costs. Treatment of HAI has been complicated by the rise of antimicrobial resistance (AMR). AMR limits the number of effective antibiotics available to treat HAI. Therefore, the prevention of these infections is increasingly important. Current evidence indicates that patients' colonization with multidrug-resistant organisms (MDRO) is a critical issue with the potential of causing serious harm. Fortunately, newer strategies such as copper usage in the healthcare environment are under development and these approaches may decrease the burden of MDRO without disrupting gastrointestinal colonization resistance. This project will explore a cutting-edge strategy to decrease HAIs through the reduction of environmental reservoirs by replacement of high-touch surfaces and textiles in an intensive care unit (ICU) setting using the inherent antimicrobial properties of copper alloys. By studying the incidence of MDRO colonization of patients and rates of HAIs in patients exposed and unexposed to copper-based surfaces and textiles, the aim is to expand knowledge, to help optimize the practice of the application of antimicrobial surfaces in the ICU setting.

AIM: To establish the efficacy of the combined use of copper alloy-surfaced objects and copper-enriched textiles to reduce the burden of patients' MDRO colonization in the ICU.

METHODS: The investigators will conduct a prospective, quasi-experimental study in the ICU at the Hospital Regional de Iquique. During the first stage of the study (6 months), the investigators will determine the cumulative incidence of MDRO acquisition (primary outcome) and the incidence rate of HAIs in patients admitted to the ICU before installation of the antimicrobial copper products. During the second stage (6 months), the investigator will assess study outcomes after the installation of copper surfaces over highly touched surfaces within the patient unit.

EXPECTED RESULTS: It is expected a 30% reduction of the cumulative incidence of MDRO acquisition with respect to the control group. The investigators also expect this reduction to translate into a decrease of HAIs in the treatment versus the control group.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Iquique, Chile
        • Hospital Regional de Iquique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults (age ≥18 years)
  2. ≥ 72 h in the ICU
  3. Provide informed consent (or via an appropriate proxy, according to local requirements).

Exclusion Criteria:

(a) Patients with conditions that preclude rectal or nasal sampling, such as total colectomy with a colostomy bag, facial surgery/trauma with nasal involvement, among others.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Copper Intervention
Intervention with copper-based surfaces plus copper-enriched linen
Other: Copper-based surfaces plus copper-enriched linen
We will assess the efficacy of our intervention to decrease the acquisition of nasal and intestinal colonization with MDROs and the development of HAIs in the ICU setting.
No Intervention: Control Group
Control group without copper intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDRO acquisition
Time Frame: 12 months
To determine the cumulative incidence of MDRO acquisition in patients admitted to the ICU before and after installation of antimicrobial copper surfaces and copper-enriched textiles.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of HAIs
Time Frame: 12 months
To determine the incidence rate of HAIs in patients admitted to the ICU before and after installation of antimicrobial copper surfaces and copper-enriched textiles.
12 months
Incidence of acquisition of individual bacterial organisms
Time Frame: 12 months
To determine the cumulative incidence of acquisition of individual bacterial organisms of interest before and after installation of antimicrobial copper surfaces and copper-enriched textiles.
12 months
Individual HAI development
Time Frame: 12 months
To determine the cumulative incidence of development of each of the included HAIs separately (See 3.2.1), before and after installation of antimicrobial copper surfaces and copper-enriched textiles.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Desarrollo

Investigators

  • Principal Investigator: Jose M Munita, MD, Universidad del Desarrollo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUPRIC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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