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

Nosocomial Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678612
• Other study ID #: CODEHRdR
• Status: Completed
• Phase: N/A
• First received: August 25, 2012
• Last updated: April 9, 2014
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Codelco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 180 Months

Eligibility

Inclusion Criteria:

• patient admitted to PICU

• stay at PICU > 24 hours

• informed consent by parent/legal representative

Exclusion criteria: none

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Nosocomial Infections

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Roberto del Rio	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Codelco

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of new events of colonization with selected pathogens per 1000 patient-days at risk	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	No
Primary	Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days		Participants will be followed for the duration of hospital stay, an expected average of 6 days	No
Secondary	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.	1 year study duration	No