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Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678612
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Codelco

Study Description
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Brief Summary:
Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality. Commonly touched items in the patient care environment harbor microorganisms that may contribute to HAI risk. The purpose of this study is to assess whether placement of copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in comparison with non-copper surfaced objects.

Condition or disease Intervention/treatment Phase
Nosocomial Infections Other: Copper-alloy surfaced objects Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1012 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Copper in Reducing Health-Acquired Infections and Microbial Burden as Measured on High Touch Surfaces in a Pediatric Intensive Care Unit. A Controlled Clinical Trial.
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Non copper standard surfaced objects
Rooms assigned to standard surfaced objects
Experimental: Copper-alloy surfaced objects
Rooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles.
 Other: Copper-alloy surfaced objects
Room assigned to the Experimental arm will be furnished with copper-alloy surfaced objects,i.e. bed-rails, bed-rail levers, IV poles, nurse workstation, HCW clipboards, sink handles.


Outcome Measures
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Primary Outcome Measures :
  1. Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ]

Secondary Outcome Measures :
  1. Microbial Burden measured on high-touch copper and non-copper surfaced objects [ Time Frame: 1 year study duration ]
    Total microbial burden and selected bacteria (MRSA,VRE) will be measured twice a month in all bedrails and sink handles of the PICU study site.


Other Outcome Measures:
  1. Incidence of new events of colonization with selected pathogens per 1000 patient-days at risk [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    Patients with negative culture (from skin and mucosa samples) will be sampled at Day 3, Day 6 and discharge.


Eligibility Criteria
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Ages Eligible for Study:   up to 180 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient admitted to PICU
  • stay at PICU > 24 hours
  • informed consent by parent/legal representative

Exclusion criteria: none

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678612


Locations
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Chile
Hospital Roberto del Rio
Santiago, Chile
Sponsors and Collaborators
Codelco
Investigators
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Principal Investigator: Bettina von Dessauer, MD Hospital Roberto del Rio
More Information
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Responsible Party: Codelco
ClinicalTrials.gov Identifier: NCT01678612    
Other Study ID Numbers: CODEHRdR
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by Codelco:
Copper
Health-Acquired Infections
Bacterial Load
Intensive Care Units, Pediatric
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
 Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs