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

U

Universidad del Desarrollo

Status

Completed

Conditions

Healthcare Associated Infection

Treatments

Other: Copper-based surfaces plus copper-enriched linen

Study type

Interventional

Funder types

Other

Identifiers

NCT04873557
CUPRIC001

Details and patient eligibility

About

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.

Full 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.

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

168 participants in 2 patient groups

Copper Intervention
Experimental group
Description:
Intervention with copper-based surfaces plus copper-enriched linen
Treatment:
Other: Copper-based surfaces plus copper-enriched linen
Control Group
No Intervention group
Description:
Control group without copper intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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