NCT01678612

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

August 25, 2012

Last Update Submit

April 9, 2014

Conditions

Nosocomial Infections

Keywords

CopperHealth-Acquired InfectionsBacterial LoadIntensive Care Units, Pediatric

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Microbial Burden measured on high-touch copper and non-copper surfaced objects

    1 year study duration

Other Outcomes (1)

  • Incidence of new events of colonization with selected pathogens per 1000 patient-days at risk

    participants will be followed for the duration of hospital stay, an expected average of 6 days

Study Arms (2)

Non copper standard surfaced objects

NO INTERVENTION

Rooms assigned to standard surfaced objects

Copper-alloy surfaced objects

EXPERIMENTAL

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

Interventions

Copper-alloy surfaced objectsOTHER

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.

Copper-alloy surfaced objects

Eligibility Criteria

Age7 Days - 180 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Roberto del Rio

Santiago, Chile

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bettina von Dessauer, MD

    Hospital Roberto del Rio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2012

First Posted

September 5, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations

CL(1)