Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01678612
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2012-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-09-28', 'releaseDate': '2018-02-02'}], 'estimatedResultsFirstSubmitDate': '2018-02-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1012}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-09', 'studyFirstSubmitDate': '2012-08-25', 'studyFirstSubmitQcDate': '2012-08-30', 'lastUpdatePostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of new events of colonization with selected pathogens per 1000 patient-days at risk', 'timeFrame': '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.'}], 'primaryOutcomes': [{'measure': 'Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 6 days'}], 'secondaryOutcomes': [{'measure': 'Microbial Burden measured on high-touch copper and non-copper surfaced objects', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Copper', 'Health-Acquired Infections', 'Bacterial Load', 'Intensive Care Units, Pediatric'], 'conditions': ['Nosocomial Infections']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '180 Months', 'minimumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient admitted to PICU\n* stay at PICU \\> 24 hours\n* informed consent by parent/legal representative\n\nExclusion criteria: none'}, 'identificationModule': {'nctId': 'NCT01678612', 'briefTitle': 'Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit', 'organization': {'class': 'INDUSTRY', 'fullName': 'Codelco'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'CODEHRdR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Non copper standard surfaced objects', 'description': 'Rooms assigned to standard surfaced objects'}, {'type': 'EXPERIMENTAL', 'label': 'Copper-alloy surfaced objects', 'description': 'Rooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles.', 'interventionNames': ['Other: Copper-alloy surfaced objects']}], 'interventions': [{'name': 'Copper-alloy surfaced objects', 'type': 'OTHER', '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.', 'armGroupLabels': ['Copper-alloy surfaced objects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Roberto del Rio', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Bettina von Dessauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Roberto del Rio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Codelco', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-02-02', 'type': 'RELEASE'}, {'date': '2018-09-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Codelco'}}}}