Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 11:29 PM
Study NCT ID:
NCT04927806
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In this study, we conduct a cluster-randomized crossover, multicenter trial.There are two groups:\n\n1. Control group: standard ventilator circuit in odd number month.\n2. Experimental group: Silver Knight in even number month'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacterial contamination', 'timeFrame': 'one month', 'description': 'comparison of the two ventilator systems'}], 'secondaryOutcomes': [{'measure': 'bacterial detection rate', 'timeFrame': 'one month', 'description': 'comparison of the two ventilator systems'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bacterial contamination', 'nosocomail infection', 'bacterial detection rate'], 'conditions': ['Bacterial Contamination']}, 'referencesModule': {'references': [{'pmid': '27714706', 'type': 'BACKGROUND', 'citation': "Zilahi G, Artigas A, Martin-Loeches I. What's new in multidrug-resistant pathogens in the ICU? Ann Intensive Care. 2016 Dec;6(1):96. doi: 10.1186/s13613-016-0199-4. Epub 2016 Oct 6."}, {'pmid': '40052538', 'type': 'DERIVED', 'citation': 'Chao KY, Liu WL, Chen CY, Su CH, Yang SH, Huang YT. Bacterial Colonization of Silver-Additive Ventilator Circuit in Patients Receiving Mechanical Ventilation: A Randomized Controlled Trial. Clin Respir J. 2025 Mar;19(3):e70058. doi: 10.1111/crj.70058.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigates the effectiveness of antimicrobial breathing system on multidrug-resistant organisms (MDRO).', 'detailedDescription': 'Background:\n\nCross transmission via skin contact and environmental media is the main route for common outbreak of health care-associated infection which more likely to be improved or prevented by infection control program. Silver Knight uses silver ions to disrupt the normal enzymatic activities of bacteria for reducing microbial growth within, and on, the surface of the breathing systems. It functions as a safe, quick and effective catalyst to deactivate pathogenic bacteria and prevent their proliferation. However, there was no study comparing the standard ventilator circuit with Silver Knight. This study focuses on the effectiveness of antimicrobial breathing system in MDRO which including carbapenem-resistant, vancomycin-resistant and multi-drug resistant.\n\nStudy Design:\n\nThis is a prospective, randomized study in a single hospital in the intensive care unit.\n\nMethods:\n\nIn this study, we conduct a cluster-randomized crossover, single-centre trial. There are two groups:\n\n1. Control group: standard ventilator circuit in odd number month.\n2. Experimental group: Silver Knight in even number month This study is expected to recruit 200 subjects. During this period, the ventilator circuits are all routinely used, only the tubing will not be discarded after use for specimen collection.And the MDRO on the surfaces of ventilator circuits will be analyzed and evaluated.\n\nEffect:\n\nWe expect the antimicrobial breathing system could be more effectively than the standard ventilator circuit. The policy related to current ventilator circuit will be revised according to the results of this study.\n\nKey words:\n\nAntimicrobial Breathing system, ventilator circuits, multidrug-resistant organisms (MDRO)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mechanical ventilators in Medisive CareUnit (MICU)\n\nExclusion Criteria:\n\n* Using ventilators for less than seven days'}, 'identificationModule': {'nctId': 'NCT04927806', 'briefTitle': 'The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms', 'orgStudyIdInfo': {'id': 'PL-202108037M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SilverKnight group', 'description': 'Silver Knight is an anti-microbial additive that uses silver ions to disrupt the normal enzymatic activities of bacteria', 'interventionNames': ['Device: Silver Knight']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group uses standard ventilator circuits.'}], 'interventions': [{'name': 'Silver Knight', 'type': 'DEVICE', 'description': 'Silver Knight breathing systems are all validated for up to seven days use, and remain active, in unopened packaging, for up to five years. Silver Knight is proven to help reduce the incidence of MRSA infection and other organisms including:\n\n* Staphyloccus epidermis\n* Pseudomonas aeruginosa\n* Klebsiella pneumoniae\n* Acinetobacter calcoaceticus\n* Escherichia coli', 'armGroupLabels': ['SilverKnight group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'Wen-Lun Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Group leader of Respiratory Therapists', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}