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

Primary Purpose

Healthcare Associated Infection

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Copper-based surfaces plus copper-enriched linen
Sponsored by
Universidad del Desarrollo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthcare Associated Infection focused on measuring Healthcare Associated Infection, Multidrug-Resistant Organism, Carbapenem-resistant Enterobacterial, Methicillin-resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Regional de Iquique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Copper Intervention

Control Group

Arm Description

Intervention with copper-based surfaces plus copper-enriched linen

Control group without copper intervention

Outcomes

Primary Outcome Measures

MDRO acquisition
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
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
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
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.

Full Information

First Posted
November 25, 2020
Last Updated
January 18, 2023
Sponsor
Universidad del Desarrollo
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1. Study Identification

Unique Protocol Identification Number
NCT04873557
Brief Title
Copper Use as Protection Against Antimicrobial Resistance in the ICU
Acronym
CUPRIC
Official Title
Copper Use as Protection Against Antimicrobial Resistance in the ICU
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Desarrollo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Associated Infection
Keywords
Healthcare Associated Infection, Multidrug-Resistant Organism, Carbapenem-resistant Enterobacterial, Methicillin-resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus, Intensive Care Unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Copper Intervention
Arm Type
Experimental
Arm Description
Intervention with copper-based surfaces plus copper-enriched linen
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group without copper intervention
Intervention Type
Other
Intervention Name(s)
Copper-based surfaces plus copper-enriched linen
Intervention Description
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.
Primary Outcome Measure Information:
Title
MDRO acquisition
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence Rate of HAIs
Description
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.
Time Frame
12 months
Title
Incidence of acquisition of individual bacterial organisms
Description
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.
Time Frame
12 months
Title
Individual HAI development
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Munita, MD
Organizational Affiliation
Universidad del Desarrollo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional de Iquique
City
Iquique
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30532565
Citation
Haque M, Sartelli M, McKimm J, Abu Bakar M. Health care-associated infections - an overview. Infect Drug Resist. 2018 Nov 15;11:2321-2333. doi: 10.2147/IDR.S177247. eCollection 2018.
Results Reference
background
PubMed Identifier
23571364
Citation
Salgado CD, Sepkowitz KA, John JF, Cantey JR, Attaway HH, Freeman KD, Sharpe PA, Michels HT, Schmidt MG. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol. 2013 May;34(5):479-86. doi: 10.1086/670207.
Results Reference
background
PubMed Identifier
26553403
Citation
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.
Results Reference
background
PubMed Identifier
31138574
Citation
Tamma PD, Kazmi A, Bergman Y, Goodman KE, Ekunseitan E, Amoah J, Simner PJ. The Likelihood of Developing a Carbapenem-Resistant Enterobacteriaceae Infection during a Hospital Stay. Antimicrob Agents Chemother. 2019 Jul 25;63(8):e00757-19. doi: 10.1128/AAC.00757-19. Print 2019 Aug.
Results Reference
background
PubMed Identifier
16153484
Citation
Kourbatova EV, Halvosa JS, King MD, Ray SM, White N, Blumberg HM. Emergence of community-associated methicillin-resistant Staphylococcus aureus USA 300 clone as a cause of health care-associated infections among patients with prosthetic joint infections. Am J Infect Control. 2005 Sep;33(7):385-91. doi: 10.1016/j.ajic.2005.06.006.
Results Reference
background
PubMed Identifier
27532259
Citation
Sickbert-Bennett EE, DiBiase LM, Willis TM, Wolak ES, Weber DJ, Rutala WA. Reduction of Healthcare-Associated Infections by Exceeding High Compliance with Hand Hygiene Practices. Emerg Infect Dis. 2016 Sep;22(9):1628-30. doi: 10.3201/eid2209.151440.
Results Reference
background
PubMed Identifier
22173515
Citation
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.
Results Reference
background
PubMed Identifier
30231949
Citation
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.
Results Reference
background
PubMed Identifier
22553242
Citation
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.
Results Reference
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Copper Use as Protection Against Antimicrobial Resistance in the ICU

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