Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-20 @ 3:38 AM
Study NCT ID:
NCT03748069
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influenza Associated Aspergillosis In-depth Investigation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055744', 'term': 'Invasive Pulmonary Aspergillosis'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, white cells, broncho-alveolar lavage fluid, lung tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Immunophenotyping of blood will be performed to determine number of neutrophils, T- and B-cell subsets, NK cell and myeloid cell subsets. Difference in influenza positive and influenza negative patients is expected.'}, {'measure': 'Difference in cytokine production of mononuclear cells to fungal stimulation in blood between influenza and non-influenza CAPIV patients at ICU.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Key cytokine reaction of mononuclear cells (PBMC) after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.'}, {'measure': 'Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Functional analysis by killing assay will be performed.'}, {'measure': 'Difference in in immune cell profile in BAL fluid between influenza and non-influenza CAPIV patients at ICU.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Immunophenotyping of BAL fluid will be performed to determine number of neutrophils, T- and B-cell subsets, NK cell and myeloid cell subsets. Difference in influenza positive and influenza negative patients is expected.'}, {'measure': 'Difference in cytokine production of mononuclear cells to fungal stimulation in BAL fluid between influenza and non-influenza CAPIV patients at ICU.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Key cytokine reaction of mononuclear BAL fluid cells after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.'}, {'measure': 'Difference in function of BAL fluid neutrophils between influenza and non-influenza CAPIV patients at ICU.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Functional analysis by killing assay will be performed.'}, {'measure': 'Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Biopsies of respiratory tract tissue will be compared between two groups.'}], 'secondaryOutcomes': [{'measure': 'Difference in longitudinal alterations in phagocytic cell and mononuclear inflammatory cell subsets in blood and BAL fluid and their response to fungal stimulation between the main study arms.', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Longitudinal alterations in advanced immunophenotyping results and (fungal) cell stimulation will be analysed and compared between groups.'}, {'measure': 'Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'Respiratory tract biopsies will be compared longitudinally throughout the disease course.'}, {'measure': 'Correlation of findings with invasive pulmonary aspergillosis incidence', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'All data will be compared within each group between patients that develop IPA vs no development of IPA.'}, {'measure': 'Correlation of findings with outcome', 'timeFrame': 'through study completion, after 3 influenza seasons (3 years)', 'description': 'All data will be compared to outcome measures (length of ICU stay, mortality, etc) to find hallmarks of severe disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'IPA', 'ICU', 'Immunology'], 'conditions': ['Influenza With Pneumonia', 'Invasive Pulmonary Aspergillosis']}, 'descriptionModule': {'briefSummary': 'This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.', 'detailedDescription': 'This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU, and correlate findings with occurrence of secondary invasive pulmonary aspergillosis infection.\n\nAll consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill community-acquired pneumonia patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients older than 18 years, admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)\n* All patients older than 18 years, admitted to ICU for respiratory distress due to community- acquired pneumonia , with a microbiologically confirmed absence of influenza (for inclusion in the control group)\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Pregnant women\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT03748069', 'acronym': 'PIAS', 'briefTitle': 'Influenza Associated Aspergillosis In-depth Investigation', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study', 'orgStudyIdInfo': {'id': 'PIAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Influenza positive CAPIV', 'description': 'All consecutive patients older than 18 years, admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza'}, {'label': 'Influenza negative CAPIV', 'description': 'All consecutive patients older than 18 years, admitted to the ICU for respiratory distress due to community-acquired pneumonia (CAP) and with a microbiologically confirmed absence of influenza'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Joost Wauters, PhD', 'role': 'CONTACT', 'email': 'joost.wauters@uzleuven.be', 'phone': '16344275', 'phoneExt': '+32'}], 'facility': 'Universitaire Ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Joost Wauters, PhD', 'role': 'CONTACT', 'email': 'joost.wauters@uzleuven.be', 'phone': '16344275', 'phoneExt': '+32'}, {'name': 'Lore Vanderbeke, MD', 'role': 'CONTACT', 'email': 'lore.vanderbeke@uzleuven.be', 'phone': '16344275', 'phoneExt': '+32'}], 'overallOfficials': [{'name': 'Joost Wauters, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}