<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01678612</url>
  </required_header>
  <id_info>
    <org_study_id>CODEHRdR</org_study_id>
    <nct_id>NCT01678612</nct_id>
  </id_info>
  <brief_title>Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Codelco</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Codelco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality.&#xD;
      Commonly touched items in the patient care environment harbor microorganisms that may&#xD;
      contribute to HAI risk. The purpose of this study is to assess whether placement of&#xD;
      copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in&#xD;
      comparison with non-copper surfaced objects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbial Burden measured on high-touch copper and non-copper surfaced objects</measure>
    <time_frame>1 year study duration</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of new events of colonization with selected pathogens per 1000 patient-days at risk</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Patients with negative culture (from skin and mucosa samples) will be sampled at Day 3, Day 6 and discharge.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1012</enrollment>
  <condition>Nosocomial Infections</condition>
  <arm_group>
    <arm_group_label>Non copper standard surfaced objects</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Rooms assigned to standard surfaced objects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Copper-alloy surfaced objects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Copper-alloy surfaced objects</intervention_name>
    <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.</description>
    <arm_group_label>Copper-alloy surfaced objects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient admitted to PICU&#xD;
&#xD;
          -  stay at PICU &gt; 24 hours&#xD;
&#xD;
          -  informed consent by parent/legal representative&#xD;
&#xD;
        Exclusion criteria: none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>180 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bettina von Dessauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Roberto del Rio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Roberto del Rio</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>April 9, 2014</last_update_submitted>
  <last_update_submitted_qc>April 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Copper</keyword>
  <keyword>Health-Acquired Infections</keyword>
  <keyword>Bacterial Load</keyword>
  <keyword>Intensive Care Units, Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>February 2, 2018</submitted>
    <returned>September 28, 2018</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01678612
org study id: CODEHRdR
nct id: NCT01678612
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 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
measure: Microbial Burden measured on high-touch copper and non-copper surfaced objects
time frame: 1 year study duration
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.
measure: 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
description: Patients with negative culture (from skin and mucosa samples) will be sampled at Day 3, Day 6 and discharge.
arm group label: Non copper standard surfaced objects
arm group type: No Intervention
description: Rooms assigned to standard surfaced objects
arm group label: Copper-alloy surfaced objects
arm group type: Experimental
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: Copper-alloy surfaced objects
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.
arm group label: Copper-alloy surfaced objects
criteria: 
gender: All
minimum age: 7 Days
maximum age: 180 Months
healthy volunteers: No
last name: Bettina von Dessauer, MD
role: Principal Investigator
affiliation: Hospital Roberto del Rio
facility: 
country: Chile
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Cross Infection
mesh term: Copper
submitted: February 2, 2018
returned: September 28, 2018