Copper Use as Protection Against Antimicrobial Resistance in the ICU
- Conditions
- Healthcare Associated Infection
- Interventions
- Other: Copper-based surfaces plus copper-enriched linen
- Registration Number
- NCT04873557
- Lead Sponsor
- Universidad del Desarrollo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
- Adults (age ≥18 years)
- ≥ 72 h in the ICU
- Provide informed consent (or via an appropriate proxy, according to local requirements).
(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Copper Intervention Copper-based surfaces plus copper-enriched linen Intervention with copper-based surfaces plus copper-enriched linen
- Primary Outcome Measures
Name Time Method MDRO acquisition 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.
- Secondary Outcome Measures
Name Time Method Individual HAI development 12 months 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.
Incidence Rate of HAIs 12 months 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 12 months 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.
Trial Locations
- Locations (1)
Hospital Regional de Iquique
🇨🇱Iquique, Chile