Healthcare Associated InfectionCUPRICNCT04873557
Copper Use as Protection Against Antimicrobial Resistance in the ICU
A study testing Copper-based surfaces plus copper-enriched linen in people with Healthcare Associated Infection, run by Universidad del Desarrollo at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Associated Infection
- What is being tested?
- Copper-based surfaces plus copper-enriched linen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChile
- Study dates
- 2 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥18 years)
- ≥ 72 h in the ICU
- Provide informed consent (or via an appropriate proxy, according to local requirements).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Copper-based surfaces plus copper-enriched linen
- Keywords
- Healthcare Associated Infection, Multidrug-Resistant Organism, Carbapenem-resistant Enterobacterial, Methicillin-resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus, Intensive Care Unit
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper-based surfaces plus copper-enriched linenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Copper Intervention | Experimental | Intervention with copper-based surfaces plus copper-enriched linen Receives: Other: Copper-based surfaces plus copper-enriched linen |
| Control Group | No intervention | Control group without copper intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start2 Nov 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Healthcare Associated InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose M Munita, Universidad del Desarrollo
- Investigators
- Jose M Munita, MD, Principal investigator, Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873557
- Sponsor's protocol ID
- CUPRIC001
- Acronym
- CUPRIC
- Status last verified
- Jan 2023
- First submitted
- 25 Nov 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30532565Salgado 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.
PubMed 23571364Schmidt 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.
PubMed 26553403Tamma 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.
PubMed 31138574Kourbatova 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.
PubMed 16153484Sickbert-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.
PubMed 27532259Karpanen 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.
PubMed 22173515Madden 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.
PubMed 30231949Schmidt 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.
PubMed 22553242
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copper Use as Protection Against Antimicrobial Resistance in the ICU
- ClinicalTrials.gov ID
- NCT04873557
- Acronym / sponsor ID
- CUPRIC / CUPRIC001
- Conditions
- Healthcare Associated Infection
- Keywords
- Healthcare Associated Infection, Multidrug-Resistant Organism, Carbapenem-resistant Enterobacterial, Methicillin-resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper Intervention | Experimental | Other: Copper-based surfaces plus copper-enriched linenIntervention with copper-based surfaces plus copper-enriched linen |
| Control Group | No intervention | –Control group without copper intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age ≥18 years)
- ≥ 72 h in the ICU
- Provide informed consent (or via an appropriate proxy, according to local requirements).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper-based surfaces plus copper-enriched linenWe 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. | Other | Copper Intervention |
Primary outcome
MDRO acquisition
Time frame: 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.
3 secondary outcomes
Incidence Rate of HAIs
Time frame: 12 months
Incidence of acquisition of individual bacterial organisms
Time frame: 12 months
Individual HAI development
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 30532565Haque 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.
- Background: PubMed 23571364Salgado 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.
- Background: PubMed 26553403Schmidt 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.
- Background: PubMed 31138574Tamma 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.
- Background: PubMed 16153484Kourbatova 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.
- Background: PubMed 27532259Sickbert-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.
- Background: PubMed 22173515Karpanen 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.
- Background: PubMed 30231949Madden 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.
- Background: PubMed 22553242Schmidt 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.
- Individual participant dataSharing planned: No
Related trials for Healthcare Associated Infection
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruitingObservational study
Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
Cross Infection, Intensive Care Units
Enrolling by invitationObservational study
Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria
Cystic Fibrosis, Nontuberculous Mycobacterial Pulmonary Infection
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose M Munita, MD principal investigator
Universidad del Desarrollo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper-based surfaces plus copper-enriched linen in people with Healthcare Associated Infection, run by Universidad del Desarrollo at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDRO acquisition (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873557, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.