Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-11 @ 11:02 AM
Study NCT ID:
NCT02392858
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2015-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Influenza Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2015-03-13', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission', 'timeFrame': 'The first, third, fifth and seventh day of hospitalization in reanimation', 'description': 'decreased arterial PaO2/FiO2 ratio ≤ 100 mmHg (≤ 13.3 kPa)'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '90 days after hospitalization'}, {'measure': 'Extracorporeal membrane oxygenation requirement', 'timeFrame': '90 days after hospitalization'}, {'measure': 'SOFA score (Adult) PELOD (Pediatric)', 'timeFrame': 'The first, third, fifth and seventh day of hospitalization in reanimation', 'description': 'Elevated Score is considered as an evidence of clinical gravity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza', 'Severe Respiratory Infection']}, 'referencesModule': {'references': [{'pmid': '36112363', 'type': 'RESULT', 'citation': 'Zhang Q, Pizzorno A, Miorin L, Bastard P, Gervais A, Le Voyer T, Bizien L, Manry J, Rosain J, Philippot Q, Goavec K, Padey B, Cupic A, Laurent E, Saker K, Vanker M, Sarekannu K; COVID Human Genetic Effort; Etablissement Francais du Sang Study Group; Constances Cohort; 3C-Dijon Study; Cerba HealthCare Group; Lyon Antigrippe Working Group; REIPI INF Working Group; Garcia-Salum T, Ferres M, Le Corre N, Sanchez-Cespedes J, Balsera-Manzanero M, Carratala J, Retamar-Gentil P, Abelenda-Alonso G, Valiente A, Tiberghien P, Zins M, Debette S, Meyts I, Haerynck F, Castagnoli R, Notarangelo LD, Gonzalez-Granado LI, Dominguez-Pinilla N, Andreakos E, Triantafyllia V, Rodriguez-Gallego C, Sole-Violan J, Ruiz-Hernandez JJ, Rodriguez de Castro F, Ferreres J, Briones M, Wauters J, Vanderbeke L, Feys S, Kuo CY, Lei WT, Ku CL, Tal G, Etzioni A, Hanna S, Fournet T, Casalegno JS, Queromes G, Argaud L, Javouhey E, Rosa-Calatrava M, Cordero E, Aydillo T, Medina RA, Kisand K, Puel A, Jouanguy E, Abel L, Cobat A, Trouillet-Assant S, Garcia-Sastre A, Casanova JL. Autoantibodies against type I IFNs in patients with critical influenza pneumonia. J Exp Med. 2022 Nov 7;219(11):e20220514. doi: 10.1084/jem.20220514. Epub 2022 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient (Adult or Pediatric)\n* Hospitalized in reanimation\n* With a laboratory confirmed Influenza\n* That agree to take part in the study\n* Affiliated to National Health Insurance\n\nFor ancillary group :\n\n* Adult at least 60 years old\n* Presenting at hospital for a blood test\n\nExclusion Criteria:\n\n* non willing to participate\n* Influenza infection with no respiratory symptoms\n* pregnancy\n\nFor ancillary group :\n\n* Presence of immunodepression defined by:\n\n * Cancer, or cancer cured for less than 2 years\n * Corticosteroids, Methotrexate (MTX), anti Tumor Necrosis Factor (TNF), anti-CD20\n* Infection in progress (fever)'}, 'identificationModule': {'nctId': 'NCT02392858', 'acronym': 'ANTIGRIPPE', 'briefTitle': 'Severe Influenza Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress', 'orgStudyIdInfo': {'id': '2014-A01023-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'influenza cohort', 'description': "Influenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation.\n\n1 control group of 30 patients (ancillary study) will be constitued to have reference values of the HLA-G5 marker.\n\nSecondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.", 'interventionNames': ['Other: influenza cohort']}], 'interventions': [{'name': 'influenza cohort', 'type': 'OTHER', 'description': "Influenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.", 'armGroupLabels': ['influenza cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Centre de Biologie et de Pathologie Nord', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU service réanimation adulte', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU service réanimation pédiatrique', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU service réanimation adulte', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU service réanimation pédiatrique', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU service réanimation adulte', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU service réanimation pédiatrique', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre de Biologie et Pathologie Est', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse-service réanimation adulte chirurgicale', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse-service réanimation adulte médicale', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Service de Réanimation Adulte', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Service de Réanimation Pédiatrique', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jean-Sebastien CASALEGNO, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPICES CIVILS DE LYON, Virology Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}