Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
This study is currently recruiting participants.
Verified November 2012 by Codelco
Sponsor:
Codelco
Information provided by (Responsible Party):
Codelco
ClinicalTrials.gov Identifier:
NCT01678612
First received: August 25, 2012
Last updated: November 13, 2012
Last verified: November 2012
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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.
| Estimated Enrollment: | 1100 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678612
Locations
| Chile | |
| Hospital Roberto del Rio | Recruiting |
| Santiago, Chile | |
| Contact: Bettina von Dessauer, MD +5627355516 | |
| Principal Investigator: Bettina von Dessauer, MD | |
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: | November 13, 2012 |
| Health Authority: | Chile: Institutional Review Board |
Keywords provided by Codelco:
|
Copper Health-Acquired Infections Bacterial Load Intensive Care Units, Pediatric |
Additional relevant MeSH terms:
|
Cross Infection Infection Copper Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013