CUPRIC: Copper Use as Protection Against Antimicrobial Resistance in the ICU

Sponsor

Universidad del Desarrollo (Other)

Overall Status

Recruiting

CT.gov ID

NCT04873557

Collaborator

(none)

170

Enrollment

Location

Arms

23.9

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthcare Associated Infection	Other: Copper-based surfaces plus copper-enriched linen	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Copper Use as Protection Against Antimicrobial Resistance in the ICU

Actual Study Start Date :

Nov 2, 2020

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

MDRO acquisition [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.

Secondary Outcome Measures

Incidence Rate of HAIs [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.
Incidence of acquisition of individual bacterial organisms [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.
Individual HAI development [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults (age ≥18 years)
≥ 72 h in the ICU
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.