Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-04-09 @ 5:48 AM
Study NCT ID:
NCT01839760
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2013-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2013-04-08', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral load/Viral shedding', 'timeFrame': 'Day 7', 'description': 'Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)'}, {'measure': 'Viral load/Viral shedding', 'timeFrame': 'Day 9', 'description': 'Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)'}, {'measure': 'Viral load/Viral shedding', 'timeFrame': 'Day 11', 'description': 'Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)'}, {'measure': 'Viral load/Viral shedding', 'timeFrame': 'Day 13', 'description': 'Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)'}, {'measure': 'Viral load/Viral shedding', 'timeFrame': 'Day 15', 'description': 'Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Virus', 'Viral shedding', 'Epidemiology'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The objective of the study is virological assessment (e.g., proportion of prolonged viral shedding, median days to viral clearance, and viral load) in laboratory-confirmed adult influenza patients admitted to the general ward and/or to the ICU and to assess the correlation with the clinical manifestations and prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized adult patients with laboratory-confirmed influenza A or B', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Hospitalized or admitted to ICU for influenza\n* Age ≥18 years\n* Laboratory confirmation of influenza A or B\n\nExclusion Criteria:\n\n* Informed consent not given'}, 'identificationModule': {'nctId': 'NCT01839760', 'briefTitle': 'Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crucell Holland BV'}, 'officialTitle': 'Prospective Study to Evaluate Viral Shedding Patterns and Clinical Outcomes of Hospitalized Adult Influenza Patients', 'orgStudyIdInfo': {'id': 'FLU-EPI-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inpatient cohort', 'description': 'Patients admitted to general wards'}, {'label': 'ICU cohort', 'description': 'Patients admitted to ICU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': 'M2K 1E1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North York General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crucell Holland BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}