Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-05 @ 7:53 PM
Study NCT ID:
NCT04242706
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2020-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-16', 'releaseDate': '2023-02-07'}], 'estimatedResultsFirstSubmitDate': '2023-02-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinded, the two devices have the same appearance.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Controlled study. Two interventions:\n\n1. Endotracheal tube with evacuation lumen without Bactiguard coating.\n2. Endotracheal tube with evacuation lumen with Bactiguard coating.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-19', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-24', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of microbial data', 'timeFrame': 'Up to 28 days of intubation after inclusion', 'description': 'Amount and type of bacteria, resistance pattern'}, {'measure': 'Evaluation of durability of the coating metals at the surface during use', 'timeFrame': 'Up to 28 days of intubation after inclusion'}], 'primaryOutcomes': [{'measure': 'VAP incidence', 'timeFrame': 'Up to 28 days after inclusion', 'description': 'Ventilator Associated Pneumonia incidence'}], 'secondaryOutcomes': [{'measure': 'Nosocomial infections', 'timeFrame': 'Up to 28 days after inclusion', 'description': 'Incidence of any kind of nosocomial infection'}, {'measure': 'VAT incidence', 'timeFrame': 'Up to 28 days after inclusion', 'description': 'Ventilator Associated Tracheabronchitis incidence'}, {'measure': 'Antibiotics consumption', 'timeFrame': 'Up to 28 days after inclusion'}, {'measure': 'Duration of ventilation', 'timeFrame': 'Up to 28 days after inclusion', 'description': 'Days of intubation with study tube'}, {'measure': 'Duration of ICU and hospital stay', 'timeFrame': 'Up to 28 days after inclusion'}, {'measure': 'Mortality', 'timeFrame': 'Up to 60 days after inclusion'}, {'measure': 'Tracheal bacterial colonization', 'timeFrame': 'Up to 28 days after inclusion', 'description': 'Incidence of tracheal bacterial colonization reaching a CFU Count 10\\^6 CFU/ml'}, {'measure': 'VAC and iVAC', 'timeFrame': 'Up to 28 days after inclusion', 'description': 'Ventilator associated Condition and infectious iVAC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator-associated Pneumonia']}, 'referencesModule': {'references': [{'pmid': '34981245', 'type': 'DERIVED', 'citation': 'Damas P, Legrain C, Lambermont B, Dardenne N, Guntz J, Kisoka G, Demaret P, Rousseau AF, Jadot L, Piret S, Noirot D, Bertrand A, Donneau AF, Misset B. Prevention of ventilator-associated pneumonia by noble metal coating of endotracheal tubes: a multi-center, randomized, double-blind study. Ann Intensive Care. 2022 Jan 4;12(1):1. doi: 10.1186/s13613-021-00961-y.'}]}, 'descriptionModule': {'briefSummary': 'The study objective is to determine VAP (Ventilator Associated Pneumonia) baseline incidence in the ICU in patients receiving endotracheal tubes with evacuation lumen with and without Bactiguard coating. The study is randomized, prospective, controlled and blinded. All adult patients hospitalized in the ICUs from two tertiary hospitals (i.e.: Centre Hospitalier Universitaire Sart Tilman Liège , Centre Hospitalier Chrétien de Liège) and considered to be ventilated for more than 24 hours will be eligible to participate in the study.', 'detailedDescription': 'The aim of the study is to determine VAP (Ventilator Associated Pneumonia) baseline incidence in the ICU in patients receiving endotracheal tubes with evacuation lumen with and without Bactiguard Infection Protection (BIP) coating.\n\nVAP is likely to occur in 10-20% of patients who are ventilated for at least 48 hours. These patients face a mortality risk estimated to be twice as high compared with similar ICU patients without VAP. Furthermore, VAP results in an average excess length of ICU stay with high hospital cost.\n\nBactiguard has developed an endotracheal tube coated with a thin layer of non-releasing metals (gold, silver and palladium) firmly attached to the surface. This Bactiguard coating is tissue friendly and aims to achieve an optimal combination of anti-infective properties to reduce biofilm formation, colonization and subsequent respiratory infection. Bactiguard coated urinary products have been on market since 1995 (initially in US, then also in Japan \\& Europe) and used in a large number of clinical studies and evaluations, showing reduction of urinary tract infections and also antibiotics use. A BIP ETT (without evacuation lumen) clinical safety and tolerability study was performed at Karolinska University Hospital during 20128. The study showed that BIP ETT is safe, well tolerable and performs well in clinical settings.\n\nThe present study of BIP ETT with evacuation lumen is randomized, prospective, controlled and blinded. All adult ICU patients hospitalized in the ICUs from two tertiary hospitals (i.e.: Centre Hospitalier Universitaire Sart Tilman Liège , Centre Hospitalier Chrétien de Liège) and considered to be ventilated for more than 24 hours will be eligible to participate in the study. 300 patients in total will be used to determine baselines levels (150 in each group).\n\nThe study tubes will be available not only in the ICUs but also in the emergency department, including the emergency vehicles, and in every hospital wards. The study tubes will not be available in the operating rooms except in the Post Anesthesia Care Units (PACU) and Recovery rooms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intubation with a study tube and a presumed duration of ventilation for more than 24h,\n* age \\> 18 y,\n* signed informed consent\n\nExclusion Criteria:\n\n* tracheostomized patient\n* life expectancy less than 48h,\n* previous participation in the study\n* pregnant women.'}, 'identificationModule': {'nctId': 'NCT04242706', 'acronym': 'VITAL', 'briefTitle': 'VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bactiguard AB'}, 'officialTitle': 'VITAL - VAP Prevention in ICU by BACTIGUARD coAting of endotracheaL Tube', 'orgStudyIdInfo': {'id': 'PL-13674'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Endotracheal tube with evacuation lumen without Bactiguard coating.', 'interventionNames': ['Device: ETTEvac']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Endotracheal tube with evacuation lumen with Bactiguard coating.', 'interventionNames': ['Device: BIP ETTEvac']}], 'interventions': [{'name': 'ETTEvac', 'type': 'DEVICE', 'description': 'Endotracheal tube with evacuation lumen without noble metal coating', 'armGroupLabels': ['Control group']}, {'name': 'BIP ETTEvac', 'type': 'DEVICE', 'description': 'Endotracheal tube with evacuation lumen with noble metal coating', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Sart Tilman Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Liège', 'country': 'Belgium', 'facility': "Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance)", 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Benoit Misset, MD,Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU, Liege; Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bactiguard AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-02-07', 'type': 'RELEASE'}, {'date': '2023-11-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bactiguard AB'}}}}