Back to resultsEfficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
Primary Purpose
Nosocomial Infections
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Copper-alloy surfaced objects
Sponsored by
About this trial
This is an interventional prevention trial for Nosocomial Infections focused on measuring Copper, Health-Acquired Infections, Bacterial Load, Intensive Care Units, Pediatric
Eligibility Criteria
Inclusion Criteria:
- patient admitted to PICU
- stay at PICU > 24 hours
- informed consent by parent/legal representative
Exclusion criteria: none
Sites / Locations
- Hospital Roberto del Rio
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non copper standard surfaced objects
Copper-alloy surfaced objects
Arm Description
Rooms assigned to standard surfaced objects
Rooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles.
Outcomes
Primary Outcome Measures
Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days
Secondary Outcome Measures
Microbial Burden measured on high-touch copper and non-copper surfaced objects
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01678612
Brief Title
Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Codelco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infections
Keywords
Copper, Health-Acquired Infections, Bacterial Load, Intensive Care Units, Pediatric
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1012 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non copper standard surfaced objects
Arm Type
No Intervention
Arm Description
Rooms assigned to standard surfaced objects
Arm Title
Copper-alloy surfaced objects
Arm Type
Experimental
Arm Description
Rooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles.
Intervention Type
Other
Intervention Name(s)
Copper-alloy surfaced objects
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Microbial Burden measured on high-touch copper and non-copper surfaced objects
Description
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.
Time Frame
1 year study duration
Other Pre-specified Outcome Measures:
Title
Incidence of new events of colonization with selected pathogens per 1000 patient-days at risk
Description
Patients with negative culture (from skin and mucosa samples) will be sampled at Day 3, Day 6 and discharge.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
180 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient admitted to PICU
stay at PICU > 24 hours
informed consent by parent/legal representative
Exclusion criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina von Dessauer, MD
Organizational Affiliation
Hospital Roberto del Rio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Roberto del Rio
City
Santiago
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
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