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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codelco
ClinicalTrials.gov Identifier:
NCT01678612
First received: August 25, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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 Intervention
Nosocomial Infections
Other: Copper-alloy surfaced objects

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Codelco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbial Burden measured on high-touch copper and non-copper surfaced objects [ Time Frame: 1 year study duration ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Patients with negative culture (from skin and mucosa samples) will be sampled at Day 3, Day 6 and discharge.


Enrollment: 1012
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 180 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678612

Locations
Chile
Hospital Roberto del Rio
Santiago, Chile
Sponsors and Collaborators
Codelco
Investigators
Principal Investigator: Bettina von Dessauer, MD Hospital Roberto del Rio
  More Information

No publications provided

Responsible Party: Codelco
ClinicalTrials.gov Identifier: NCT01678612     History of Changes
Other Study ID Numbers: CODEHRdR
Study First Received: August 25, 2012
Last Updated: April 9, 2014
Health Authority: Chile: Institutional Review Board

Keywords provided by Codelco:
Copper
Health-Acquired Infections
Bacterial Load
Intensive Care Units, Pediatric

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cross Infection
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014