Copper Use as Protection Against Antimicrobial Resistance in the ICU

NCT04873557 | Completed DMC

• 1 other identifier: CUPRIC001
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthcare Associated Infection

Keywords

Healthcare Associated Infection; Multidrug-Resistant Organism; Carbapenem-resistant Enterobacterial; Methicillin-resistant Staphylococcus aureus; Vancomycin-Resistant Enterococcus; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• Incidence Rate of HAIs

  12 months

• Incidence of acquisition of individual bacterial organisms

  12 months

• Individual HAI development

  12 months

Study Arms (2)

Copper Intervention

EXPERIMENTAL

Intervention with copper-based surfaces plus copper-enriched linen

Other: Copper-based surfaces plus copper-enriched linen

Control Group

NO INTERVENTION

Control group without copper intervention

Interventions

Copper-based surfaces plus copper-enriched linen 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.

Copper Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Universidad del Desarrollo: lead

Study Sites (1)

Hospital Regional de Iquique

Iquique, Chile

Location

Related Publications (9)

• 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.

  PMID: 30532565 BACKGROUND

• 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.

  PMID: 23571364 BACKGROUND

• 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.

  PMID: 26553403 BACKGROUND

• 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.

  PMID: 31138574 BACKGROUND

• 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.

  PMID: 16153484 BACKGROUND

• 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.

  PMID: 27532259 BACKGROUND

• 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.

  PMID: 22173515 BACKGROUND

• 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.

  PMID: 30231949 BACKGROUND

• 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.

  PMID: 22553242 BACKGROUND

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose M Munita, MD

  Universidad del Desarrollo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: May 5, 2021
• Study Start: November 2, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)