Copper Use as Protection Against Antimicrobial Resistance in the ICU

NCT ID: NCT04873557

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Healthcare Associated Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Copper Intervention

Intervention with copper-based surfaces plus copper-enriched linen

Group Type: EXPERIMENTAL

Copper-based surfaces plus copper-enriched linen

Intervention Type: OTHER

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.

Control Group

Control group without copper intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad del Desarrollo

OTHER

Sponsor Role: lead

Responsible Party

Jose M Munita

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose M Munita, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad del Desarrollo

Locations

Hospital Regional de Iquique

Iquique, , Chile

Countries

Chile

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23571364 (View on PubMed)

Schmidt MG, von Dessauer B, Benavente C, Benadof D, Cifuentes P, Elgueta A, Duran C, Navarrete MS. Copper surfaces are associated with significantly lower concentrations of bacteria on selected surfaces within a pediatric intensive care unit. Am J Infect Control. 2016 Feb;44(2):203-9. doi: 10.1016/j.ajic.2015.09.008. Epub 2015 Nov 6.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Karpanen TJ, Casey AL, Lambert PA, Cookson BD, Nightingale P, Miruszenko L, Elliott TS. The antimicrobial efficacy of copper alloy furnishing in the clinical environment: a crossover study. Infect Control Hosp Epidemiol. 2012 Jan;33(1):3-9. doi: 10.1086/663644. Epub 2011 Dec 7.

Reference Type: BACKGROUND

PMID: 22173515 (View on PubMed)

Madden GR, Heon BE, Sifri CD. Effect of copper-impregnated linens on multidrug-resistant organism acquisition and Clostridium difficile infection at a long-term acute-care hospital. Infect Control Hosp Epidemiol. 2018 Nov;39(11):1384-1386. doi: 10.1017/ice.2018.196. Epub 2018 Sep 20.

Reference Type: BACKGROUND

PMID: 30231949 (View on PubMed)

Schmidt MG, Attaway HH, Sharpe PA, John J Jr, Sepkowitz KA, Morgan A, Fairey SE, Singh S, Steed LL, Cantey JR, Freeman KD, Michels HT, Salgado CD. Sustained reduction of microbial burden on common hospital surfaces through introduction of copper. J Clin Microbiol. 2012 Jul;50(7):2217-23. doi: 10.1128/JCM.01032-12. Epub 2012 May 2.

Reference Type: BACKGROUND

PMID: 22553242 (View on PubMed)

Other Identifiers

CUPRIC001

Identifier Type: -

Identifier Source: org_study_id