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

April 9, 2014 updated by: Codelco

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1012

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Hospital Roberto del Rio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion criteria: none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year study duration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed for the duration of hospital stay, an expected average of 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Codelco

Investigators

  • Principal Investigator: Bettina von Dessauer, MD, Hospital Roberto del Rio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 25, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CODEHRdR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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