Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-31 @ 1:47 AM
Study NCT ID:
NCT04727957
Status:
UNKNOWN
Last Update Posted:
2021-04-15
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with VA-LRTI as assessed by risk-calculator', 'timeFrame': '1.6.-31.12.2021', 'description': 'Prediction model to be used at the moment of diagnosis and algorithms to be used prior IMV to predict the risk of VA-LRTI.'}], 'secondaryOutcomes': [{'measure': 'Rate of in-hospital mortality', 'timeFrame': '1.6.-31.12.2021', 'description': 'Prediction model to be used at the moment of diagnosis to predict the risk of mortality in VA-LRTIs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator-Associated Event']}, 'descriptionModule': {'briefSummary': 'To determine the accuracy and generalizability of VA-LRTI algorithm to detect and predict three high-incidence and high-impact VAEs from electronic health records data: 1) ventilator-associated event, 2) ventilator-associated pneumonia, and 3) ventilator-associated tracheobronchitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult mixed medical-surgical ICU patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'All invasively ventilated ICU patient (aged 18 or over)'}, 'identificationModule': {'nctId': 'NCT04727957', 'acronym': 'PA in VA-LRTIs', 'briefTitle': 'Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs)', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Predictive Analytics in Ventilator-Associated Events', 'orgStudyIdInfo': {'id': 'University of Oulu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dataset for development and testing', 'interventionNames': ['Other: Diagnostic and prognostic models for VA-LRTIs']}, {'label': 'Dataset for external validation', 'interventionNames': ['Other: Diagnostic and prognostic models for VA-LRTIs']}], 'interventions': [{'name': 'Diagnostic and prognostic models for VA-LRTIs', 'type': 'OTHER', 'description': 'Diagnostic and prognostic models for VA-LRTIs', 'armGroupLabels': ['Dataset for development and testing', 'Dataset for external validation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'country': 'Finland', 'contacts': [{'name': 'Miia Jansson, PhD', 'role': 'CONTACT', 'email': 'miia.jansson@oulu.fi'}], 'facility': 'Univeristy of Oulu', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'centralContacts': [{'name': 'Miia Jansson, PhD', 'role': 'CONTACT', 'email': 'miia.jansson@oulu.fi', 'phone': '+358 50 470 12 62'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor, PhD', 'investigatorFullName': 'Miia M Jansson, PhD', 'investigatorAffiliation': 'University of Oulu'}}}}