[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653554":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":68,"studyPopulation":55,"armGroups":69,"interventions":82,"overallOfficials":92,"centralContacts":97,"locations":106,"responsibleParty":676,"collaborators":678,"id":681,"slug":682,"hasResults":683,"nctId":684,"briefTitle":685,"officialTitle":686,"acronym":687,"eligibilityCriteria":688,"healthyVolunteers":683,"sex":689,"minAge":690,"maxAge":55,"enrollmentInfo":691,"targetDuration":55,"studyType":694,"phases":695,"briefSummary":697,"conditions":698,"keywords":704,"overallStatus":708,"whyStopped":55,"lastUpdateSubmitDate":709,"lastUpdatePostDateStruct":710,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":718},{"fullName":5,"class":6},"Centre Hospitalier Régional Metz-Thionville","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of ICU-free days","To compare the efficacy of dexamethasone versus placebo in patients with severe influenza on a hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of Intensive Care Unit (ICU)-free days.\n\nHierarchical composite endpoint, scored as follows:\n\n1. In-hospital death (all-cause) at day 28 (yes\u002Fno),\n2. If alive at day 28, number of ventilator-free days between (day)\n3. If mechanical ventilation never required, number of ICU-free days (day) Each patient in the intervention group will be compared with each patient in the control group according to this score: a win, loss, or tie will be defined for each pair based on which scored better.","At baseline and day 28",[14,18,21,24,27,30,33,36,40,44,48,51],{"measure":15,"description":16,"timeFrame":17},"In-hospital death","The comparison between the two study groups of In-hospital death (all-cause)","At day 28",{"measure":19,"description":20,"timeFrame":17},"Duration of extracorporeal membrane oxygenation","The comparison between the two study groups of duration of extracorporeal membrane oxygenation (ECMO) support during the study period, measured as the total number of days during which the participant receives ECMO support.\n\nUnit of Measure: Days",{"measure":22,"description":23,"timeFrame":17},"Duration of invasive mechanical ventilation","The comparaison between the two study groups of duration of invasive mechanical ventilation during the study period, measured as the total number of days during which the participant receives invasive mechanical ventilatory support.\n\nUnit of Measure: Days",{"measure":25,"description":26,"timeFrame":17},"Duration of renal replacement therapy","The comparaison between the two study groups of duration of renal replacement therapy (RRT) during the study period, measured as the total number of days during which the participant receives renal replacement therapy.\n\nUnit of Measure: Days",{"measure":28,"description":29,"timeFrame":17},"Duration of vasopressor therapy","The comparaison between the two study groups of duration of vasopressor therapy during the study period, measured as the total number of days during which the participant receives vasopressor treatment.\n\nUnit of Measure: Days",{"measure":31,"description":32,"timeFrame":17},"Days alive without life support","The comparison between the two study groups of days alive without life support Number of days alive without life support (extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation (MV), renal replacement therapy (RRT) and vasopressor) (day)",{"measure":34,"description":35,"timeFrame":17},"Duration of supplemental oxygen, non-invasive ventilation, high flow oxygen","The comparison between the two study groups of duration of supplemental oxygen, non-invasive ventilation, high flow oxygen.\n\nDuration of supplemental oxygen use (Oxygen flow rate (L\u002Fmin); fraction of inspired oxygen (FiO2)(%), non-invasive ventilation (FiO2)(%), high flow oxygen (FiO2)(%)",{"measure":37,"description":38,"timeFrame":39},"Length of stay in hospital and ICU","Length of stay in hospital and intensive care units (ICU) (day)","At day 28 and day 90",{"measure":41,"description":42,"timeFrame":43},"Viral clearance","Nasopharyngeal viral load measured (IU\u002FmL)","At baseline, day 4 and day 8",{"measure":45,"description":46,"timeFrame":47},"Change in quality of life","As determined with the 36-Item Short-Form Health Survey (SF-36) Questionnaire. It includes eight scales, with four measuring physical health and four assessing mental health. Each SF-36 subscale score ranges from 0 to 100, where higher scores indicate better health status","At day 90",{"measure":49,"description":50,"timeFrame":47},"Mortality","Assessment of mortality (yes\u002Fno)",{"measure":52,"description":53,"timeFrame":54},"Safety endpoint: occurrence of adverse events","Safety endpoint: occurrence of adverse events :\n\n1. Hyperglycaemia (i.e., need for new insulin or increase in insulin \\>30% from initial\u002Fbaseline dose) (IU)\n2. Clinically significant gastrointestinal bleeding (requiring endoscopy or red blood cell transfusion) (yes\u002Fno)\n3. Occurrence of Influenza-associated pulmonary aspergillosis (yes\u002Fno)\n4. Occurrence of ventilatory-acquired pneumonia (yes\u002Fno)\n5. New episodes of septic shock according to the Sepsis-3 criteria (yes\u002Fno)","Daily, from baseline until day 28",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","Patients will receive state-of-the-art standard therapy for severe influenza. They will be randomized in a 1:1 ratio to one of the two arms. Patients, investigators and care providers will be blinded to the patient arm. Patients will receive antiviral treatment and antibiotic therapy if bacterial co-infection is suspected","TREATMENT",{"masking":62,"maskingDescription":63,"whoMasked":64},"TRIPLE","Pharmacist",[65,66,67],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Influenza virus infections cause excessive hospitalizations and deaths during seasonal peaks and pandemics. It remains a leading cause of admission to intensive care units (ICU) for acute respiratory failure. Apart from annual vaccination and other preventive measures, early administration of neuraminidase inhibitors is the only recommended treatment, but with a low level of evidence. Corticosteroids attenuate the immune response to infection and improve outcomes in patients with several types of severe pulmonary infections. Low-dose corticosteroids have been shown to reduce mortality in patients with severe COVID-19 and communityacquired pneumonia. It may also benefit critically ill patients with acute respiratory distress syndrome by reducing mortality, duration of mechanical ventilation and length of hospital stay. Observational studies with a high risk of bias have suggested an increase in mortality in patients with influenza who receive corticosteroid therapy. Others have shown a beneficial effect of corticosteroids or no link between their use and mortality. One concern for clinicians is the risk of Influenza-associated pulmonary aspergillosis (IAPA), which affects 10-20% of patients and is associated with a poor prognosis. However, there is insufficient evidence on the effects of corticosteroids administered during the ICU stay. Based on these findings and in the absence of a randomized trial, current guidelines do not recommend corticosteroid therapy in severe influenza. Therefore, a wellpowered trial is needed to test the hypothesis that corticosteroids could improve outcomes in critically-ill patients with severe influenza and acute respiratory failure.",[70,76],{"label":71,"type":72,"description":73,"interventionNames":74},"Dexamethasone","EXPERIMENTAL","a daily dose of 6 mg dexamethasone (investigational medicinal product) suspended in sodium chloride 0.9% and administered as a masked intravenous injection (total volume of 5 ml) once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.",[75],"Drug: Dexametasone",{"label":77,"type":78,"description":79,"interventionNames":80},"Placebo","PLACEBO_COMPARATOR","a daily dose of placebo (sodium chloride 0.9%, total volume of 5 ml) intravenously once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.",[81],"Drug: Sodium chloride 0.9% (placebo)",[83,88],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":55},"DRUG","Dexametasone","Experimental Group : A daily dose of 6 mg dexamethasone (investigational medicinal product) suspended in sodium chloride 0.9% and administered as a masked intravenous injection (total volume of 5 ml) once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.",[71],{"type":84,"name":89,"description":90,"armGroupLabels":91,"otherNames":55},"Sodium chloride 0.9% (placebo)","Placebo : A daily dose of placebo (sodium chloride 0.9%, total volume of 5 ml) intravenously once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.",[77],[93],{"name":94,"affiliation":95,"role":96},"Dr. Guillaume LOUIS, MD","CHR Metz-Thionville, Hôpital de Mercy","PRINCIPAL_INVESTIGATOR",[98,103],{"name":99,"role":100,"phone":101,"phoneExt":55,"email":102},"Arpiné EL NAR, PhD","CONTACT","0033387557766","projet-recherche-clinique@chr-metz-thionville.fr",{"name":104,"role":100,"phone":105,"phoneExt":55,"email":102},"Mélanie JUNKE","0033387179886",[107,122,134,146,158,170,182,194,206,218,230,242,254,266,278,290,302,314,326,338,347,359,368,377,389,403,415,427,439,451,463,475,487,499,508,520,532,544,556,568,580,592,604,616,628,640,652,664],{"facility":108,"status":55,"city":109,"state":55,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"CH Argenteuil - Victor Dupouy","Argenteuil","95107","France","FR",{"type":114,"coordinates":115},"Point",[116,117],2.24744,48.94788,{"lat":117,"lon":116},[120],{"name":121,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Damien CONTOU, MD",{"facility":123,"status":55,"city":124,"state":55,"zip":125,"country":111,"countryCode":112,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"APHP - Hôpital Avicenne","Bobigny","93000",{"type":114,"coordinates":127},[128,129],2.45012,48.90982,{"lat":129,"lon":128},[132],{"name":133,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Stéphane GAUDRY, PUPH",{"facility":135,"status":55,"city":136,"state":55,"zip":137,"country":111,"countryCode":112,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"CH Bourg-en-Bresse - Fleyriat","Bourg-en-Bresse","01012",{"type":114,"coordinates":139},[140,141],5.2258,46.20574,{"lat":141,"lon":140},[144],{"name":145,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Adrien ROBINE, MD",{"facility":147,"status":55,"city":148,"state":55,"zip":149,"country":111,"countryCode":112,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"CHU de Caen Normandie - Hôpital Côte de Nacre","Caen","14000",{"type":114,"coordinates":151},[152,153],-0.35912,49.18585,{"lat":153,"lon":152},[156],{"name":157,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Damien DU CHEYRON, MD",{"facility":159,"status":55,"city":160,"state":55,"zip":161,"country":111,"countryCode":112,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"CH de Cannes - Simone Veil","Cannes","06400",{"type":114,"coordinates":163},[164,165],7.01275,43.55135,{"lat":165,"lon":164},[168],{"name":169,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Nicolas CLEMENT, MD",{"facility":171,"status":55,"city":172,"state":55,"zip":173,"country":111,"countryCode":112,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Centre Hospitalier Public du Cotentin","Cherbourg","50102",{"type":114,"coordinates":175},[176,177],-1.61636,49.63984,{"lat":177,"lon":176},[180],{"name":181,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Xavier SOULOY, PH",{"facility":183,"status":55,"city":184,"state":55,"zip":185,"country":111,"countryCode":112,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"APHP - Hôpital Louis Mourier","Colombes","92700",{"type":114,"coordinates":187},[188,189],2.25404,48.91882,{"lat":189,"lon":188},[192],{"name":193,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Damien ROUX, MD",{"facility":195,"status":55,"city":196,"state":55,"zip":197,"country":111,"countryCode":112,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"APHP - Hôpital Henri Mondor","Créteil","94010",{"type":114,"coordinates":199},[200,201],2.46569,48.79266,{"lat":201,"lon":200},[204],{"name":205,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Nicolas DE PROST, PUPH",{"facility":207,"status":55,"city":208,"state":55,"zip":209,"country":111,"countryCode":112,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"CHU de Dijon Bourgogne","Dijon","21000",{"type":114,"coordinates":211},[212,213],5.01391,47.31344,{"lat":213,"lon":212},[216],{"name":217,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Jean-Pierre QUENOT, MD",{"facility":219,"status":55,"city":220,"state":55,"zip":221,"country":111,"countryCode":112,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"CH Annecy Genevois - Site Annecy","Épagny","74370",{"type":114,"coordinates":223},[224,225],6.08302,45.93584,{"lat":225,"lon":224},[228],{"name":229,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. David BOUGON, MD",{"facility":231,"status":55,"city":232,"state":55,"zip":233,"country":111,"countryCode":112,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"CH Joséphine Backer - Site Gonesse","Gonesse","95503",{"type":114,"coordinates":235},[236,237],2.44892,48.98693,{"lat":237,"lon":236},[240],{"name":241,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Guillaume GELÉ-DECAUDIN, MD",{"facility":243,"status":55,"city":244,"state":55,"zip":245,"country":111,"countryCode":112,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"CH de Haguenau","Haguenau","67500",{"type":114,"coordinates":247},[248,249],7.79051,48.81557,{"lat":249,"lon":248},[252],{"name":253,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Asaël BERGER, MD",{"facility":255,"status":55,"city":256,"state":55,"zip":257,"country":111,"countryCode":112,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Centre Hospitalier Départemental Vendée - Site La Roche-Sur-Yon","La Roche-sur-Yon","85000",{"type":114,"coordinates":259},[260,261],-1.42757,46.66974,{"lat":261,"lon":260},[264],{"name":265,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Matthieu HENRY, PH",{"facility":267,"status":55,"city":268,"state":55,"zip":269,"country":111,"countryCode":112,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Groupe Hospitalier la Rochelle-Ré-Aunis - Hôpital de La Rochelle","La Rochelle","17019",{"type":114,"coordinates":271},[272,273],-1.15222,46.16308,{"lat":273,"lon":272},[276],{"name":277,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. François PERIER, PH",{"facility":279,"status":55,"city":280,"state":55,"zip":281,"country":111,"countryCode":112,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"CH de Versailles - Site André Mignot","Le Chesnay","78150",{"type":114,"coordinates":283},[284,285],2.12213,48.8222,{"lat":285,"lon":284},[288],{"name":289,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Alexis FERRÉ, MD",{"facility":291,"status":55,"city":292,"state":55,"zip":293,"country":111,"countryCode":112,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"CH Le Mans","Le Mans","72037",{"type":114,"coordinates":295},[296,297],0.20251,48.0021,{"lat":297,"lon":296},[300],{"name":301,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Cédric DARREAU, PH",{"facility":303,"status":55,"city":304,"state":55,"zip":305,"country":111,"countryCode":112,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"CHU de Lille - Hôpital Roger SALENGRO","Lille","59037",{"type":114,"coordinates":307},[308,309],3.05512,50.63391,{"lat":309,"lon":308},[312],{"name":313,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Julien POISSY, PUPH",{"facility":315,"status":55,"city":316,"state":55,"zip":317,"country":111,"countryCode":112,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Groupe Hospitalier Bretagne Sud - Hôpital du Scorff","Lorient","56100",{"type":114,"coordinates":319},[320,321],-3.37177,47.74817,{"lat":321,"lon":320},[324],{"name":325,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Flora DELAMAIRE, PH",{"facility":327,"status":55,"city":328,"state":55,"zip":329,"country":111,"countryCode":112,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"HCL - Hôpital de la Croix-Rousse","Lyon","69004",{"type":114,"coordinates":331},[332,333],4.84789,45.74906,{"lat":333,"lon":332},[336],{"name":337,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Laurent BITKER, MD",{"facility":339,"status":55,"city":328,"state":55,"zip":340,"country":111,"countryCode":112,"cosmosGeoPoint":341,"geoPoint":343,"contacts":344},"HCL - Hôpital Edouard Herriot","69437",{"type":114,"coordinates":342},[332,333],{"lat":333,"lon":332},[345],{"name":346,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Laurent ARGAUD, PUPH",{"facility":348,"status":55,"city":349,"state":55,"zip":350,"country":111,"countryCode":112,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"APHM - Hôpital de la Timone","Marseille","13005",{"type":114,"coordinates":352},[353,354],5.38107,43.29695,{"lat":354,"lon":353},[357],{"name":358,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Julien CARVELLI, MD",{"facility":360,"status":55,"city":349,"state":55,"zip":361,"country":111,"countryCode":112,"cosmosGeoPoint":362,"geoPoint":364,"contacts":365},"Institut Paoli-Calmettes","13009",{"type":114,"coordinates":363},[353,354],{"lat":354,"lon":353},[366],{"name":367,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Djamel MOKART, MD",{"facility":369,"status":55,"city":349,"state":55,"zip":370,"country":111,"countryCode":112,"cosmosGeoPoint":371,"geoPoint":373,"contacts":374},"APHM - CHU Nord","13015",{"type":114,"coordinates":372},[353,354],{"lat":354,"lon":353},[375],{"name":376,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Sami HRAIECH, PUPH",{"facility":378,"status":55,"city":379,"state":55,"zip":380,"country":111,"countryCode":112,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"GH Sud-Ile de France - CH de Melun-Sénart","Melun","77000",{"type":114,"coordinates":382},[383,384],2.65356,48.5457,{"lat":384,"lon":383},[387],{"name":388,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Mehran MONCHI, MD",{"facility":390,"status":55,"city":391,"state":55,"zip":392,"country":111,"countryCode":112,"cosmosGeoPoint":393,"geoPoint":397,"contacts":398},"CHR Metz-Thionville, Hopital de Mercy","Metz","57085",{"type":114,"coordinates":394},[395,396],6.17269,49.11911,{"lat":396,"lon":395},[399,401,402],{"name":400,"role":100,"phone":55,"phoneExt":55,"email":102},"Arpiné EL NAR",{"name":104,"role":100,"phone":55,"phoneExt":55,"email":102},{"name":94,"role":96,"phone":55,"phoneExt":55,"email":55},{"facility":404,"status":55,"city":405,"state":55,"zip":406,"country":111,"countryCode":112,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"GH Portes de Provence - Hôpital de Montélimar","Montélimar","26200",{"type":114,"coordinates":408},[409,410],4.75469,44.55468,{"lat":410,"lon":409},[413],{"name":414,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Pierre Yves LEGRAND, PH",{"facility":416,"status":55,"city":417,"state":55,"zip":418,"country":111,"countryCode":112,"cosmosGeoPoint":419,"geoPoint":423,"contacts":424},"CHU de Montpellier - Hôpital Saint Eloi","Montpellier","34295",{"type":114,"coordinates":420},[421,422],3.87635,43.61093,{"lat":422,"lon":421},[425],{"name":426,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Audrey DE JONG, PUPH",{"facility":428,"status":55,"city":429,"state":55,"zip":430,"country":111,"countryCode":112,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"CHRU de Nancy - Hôpital Central","Nancy","54035",{"type":114,"coordinates":432},[433,434],6.18496,48.68439,{"lat":434,"lon":433},[437],{"name":438,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Sébastien GIBOT, MD",{"facility":440,"status":55,"city":441,"state":55,"zip":442,"country":111,"countryCode":112,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"CHU de Nantes - Hôtel Dieu","Nantes","44093",{"type":114,"coordinates":444},[445,446],-1.55336,47.21725,{"lat":446,"lon":445},[449],{"name":450,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Jean-Baptiste LASCARROU, PH",{"facility":452,"status":55,"city":453,"state":55,"zip":454,"country":111,"countryCode":112,"cosmosGeoPoint":455,"geoPoint":459,"contacts":460},"Groupe Hospitalier Privé Ambroise Paré-Hartmann - Hôpital Ambroise Paré","Neuilly-sur-Seine","92200",{"type":114,"coordinates":456},[457,458],2.26965,48.8846,{"lat":458,"lon":457},[461],{"name":462,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Guillaume GERI, MD",{"facility":464,"status":55,"city":465,"state":55,"zip":466,"country":111,"countryCode":112,"cosmosGeoPoint":467,"geoPoint":471,"contacts":472},"CHU de Nîmes - Hôpital Caremeau","Nîmes","30029",{"type":114,"coordinates":468},[469,470],4.35788,43.83665,{"lat":470,"lon":469},[473],{"name":474,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Saber Davide BARBAR, MD",{"facility":476,"status":55,"city":477,"state":55,"zip":478,"country":111,"countryCode":112,"cosmosGeoPoint":479,"geoPoint":483,"contacts":484},"CHU d'Orléans","Orléans","45064",{"type":114,"coordinates":480},[481,482],1.90407,47.90248,{"lat":482,"lon":481},[485],{"name":486,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Grégoire MULLER, MD",{"facility":488,"status":55,"city":489,"state":55,"zip":490,"country":111,"countryCode":112,"cosmosGeoPoint":491,"geoPoint":495,"contacts":496},"APHP - Hôpital Cochin","Paris","75014",{"type":114,"coordinates":492},[493,494],2.3488,48.85341,{"lat":494,"lon":493},[497],{"name":498,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Frédéric PÈNE, PUPH",{"facility":500,"status":55,"city":489,"state":55,"zip":501,"country":111,"countryCode":112,"cosmosGeoPoint":502,"geoPoint":504,"contacts":505},"APHP - Groupe Hospitalier Bichat - Claude Bernard","75877",{"type":114,"coordinates":503},[493,494],{"lat":494,"lon":493},[506],{"name":507,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Jean-François TIMSIT, MD",{"facility":509,"status":55,"city":510,"state":55,"zip":511,"country":111,"countryCode":112,"cosmosGeoPoint":512,"geoPoint":516,"contacts":517},"CHI de Poissy Saint-Germain-en-Laye - Site Hospitalier de Poissy","Poissy","78300",{"type":114,"coordinates":513},[514,515],2.04952,48.92902,{"lat":515,"lon":514},[518],{"name":519,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Lionel LIMA DA SILVA, PH",{"facility":521,"status":55,"city":522,"state":55,"zip":523,"country":111,"countryCode":112,"cosmosGeoPoint":524,"geoPoint":528,"contacts":529},"CHU de Poitiers - Site de la Milétrie","Poitiers","86021",{"type":114,"coordinates":525},[526,527],0.34348,46.58261,{"lat":527,"lon":526},[530],{"name":531,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. François ARRIVÉ, MD",{"facility":533,"status":55,"city":534,"state":55,"zip":535,"country":111,"countryCode":112,"cosmosGeoPoint":536,"geoPoint":540,"contacts":541},"CHU de Rennes - Hôpital Pontchaillou","Rennes","35033",{"type":114,"coordinates":537},[538,539],-1.67431,48.11109,{"lat":539,"lon":538},[542],{"name":543,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Nicolas TERZI, PUPH",{"facility":545,"status":55,"city":546,"state":55,"zip":547,"country":111,"countryCode":112,"cosmosGeoPoint":548,"geoPoint":552,"contacts":553},"CH de Saint-Brieuc, Paimpol et Tréguier - Hôpital de Saint-Brieuc","Saint-Brieuc","22000",{"type":114,"coordinates":549},[550,551],-2.76838,48.51513,{"lat":551,"lon":550},[554],{"name":555,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Thomas DOUILLARD, PH",{"facility":557,"status":55,"city":558,"state":55,"zip":559,"country":111,"countryCode":112,"cosmosGeoPoint":560,"geoPoint":564,"contacts":565},"CH de Saint-Nazaire","Saint-Nazaire","44600",{"type":114,"coordinates":561},[562,563],-2.2179,47.27506,{"lat":563,"lon":562},[566],{"name":567,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Marie-Catherine BESSE, MD",{"facility":569,"status":55,"city":570,"state":55,"zip":571,"country":111,"countryCode":112,"cosmosGeoPoint":572,"geoPoint":576,"contacts":577},"Groupe Hospitalier Rance Emeraude - Site Hospitalier Broussais","St-Malo","35400",{"type":114,"coordinates":573},[574,575],-2.00877,48.64738,{"lat":575,"lon":574},[578],{"name":579,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Éric DELAVEUVE, PH",{"facility":581,"status":55,"city":582,"state":55,"zip":583,"country":111,"countryCode":112,"cosmosGeoPoint":584,"geoPoint":588,"contacts":589},"CHRU de Strasbourg - Hôpital de Hautepierre","Strasbourg","67091",{"type":114,"coordinates":585},[586,587],7.74553,48.58392,{"lat":587,"lon":586},[590],{"name":591,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Julien DEMISELLE, PH",{"facility":593,"status":55,"city":594,"state":55,"zip":595,"country":111,"countryCode":112,"cosmosGeoPoint":596,"geoPoint":600,"contacts":601},"CHR Metz-Thionville, Hôpital Bel Air","Thionville","57100",{"type":114,"coordinates":597},[598,599],6.16044,49.35994,{"lat":599,"lon":598},[602],{"name":603,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Paul DUNAND, MD",{"facility":605,"status":55,"city":606,"state":55,"zip":607,"country":111,"countryCode":112,"cosmosGeoPoint":608,"geoPoint":612,"contacts":613},"CH de Tourcoing - Hôpital Chatiliez","Tourcoing","59208",{"type":114,"coordinates":609},[610,611],3.16117,50.72391,{"lat":611,"lon":610},[614],{"name":615,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Nicolas BOUSSEKEY, PH",{"facility":617,"status":55,"city":618,"state":55,"zip":619,"country":111,"countryCode":112,"cosmosGeoPoint":620,"geoPoint":624,"contacts":625},"Hôpital Nord Franche Comté - Site Trévenans","Trévenans","90400",{"type":114,"coordinates":621},[622,623],6.86667,47.56667,{"lat":623,"lon":622},[626],{"name":627,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Julio BADIE, PH",{"facility":629,"status":55,"city":630,"state":55,"zip":631,"country":111,"countryCode":112,"cosmosGeoPoint":632,"geoPoint":636,"contacts":637},"CH de Valence","Valence","26000",{"type":114,"coordinates":633},[634,635],4.90956,44.9256,{"lat":635,"lon":634},[638],{"name":639,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Tanguy DUBOST, MD",{"facility":641,"status":55,"city":642,"state":55,"zip":643,"country":111,"countryCode":112,"cosmosGeoPoint":644,"geoPoint":648,"contacts":649},"CHRU de Nancy - Hôpitaux de Brabois","Vandœuvre-lès-Nancy","54500",{"type":114,"coordinates":645},[646,647],6.17114,48.66115,{"lat":647,"lon":646},[650],{"name":651,"role":96,"phone":55,"phoneExt":55,"email":55},"Pr. Antoine KIMMOUN, PUPH",{"facility":653,"status":55,"city":654,"state":55,"zip":655,"country":111,"countryCode":112,"cosmosGeoPoint":656,"geoPoint":660,"contacts":661},"CH Bretagne Atlantique - Site Vannes","Vannes","56000",{"type":114,"coordinates":657},[658,659],-2.76205,47.65688,{"lat":659,"lon":658},[662],{"name":663,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Florian REIZINE, MD",{"facility":665,"status":55,"city":666,"state":55,"zip":667,"country":111,"countryCode":112,"cosmosGeoPoint":668,"geoPoint":672,"contacts":673},"Hôpitaux Privés de Metz - Hôpital Robert Schuman","Vantoux","57070",{"type":114,"coordinates":669},[670,671],6.23201,49.12945,{"lat":671,"lon":670},[674],{"name":675,"role":96,"phone":55,"phoneExt":55,"email":55},"Dr. Peter ESZTO, MD",{"type":677,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR",[679],{"name":680,"class":6},"Henri Mondor University Hospital","100653554","phase-3-early-corticosteroids-in-severe-influenza-pneumonia-100653554",false,"NCT07786662","Early Corticosteroids in Severe Influenza Pneumonia","Early Corticosteroids in Severe Influenza Pneumonia, a Phase III Randomized Controlled Trial","ECSIP","Inclusion Criteria:\n\n1. Age ≥ 18 y\n2. Admission to ICU or intermediate care for less than 2 days\n3. Admission to hospital for less than 5 days\n4. Diagnosis of influenza pneumonia with\n\n   * PCR positive for Influenza dated less than 5 days\n   * AND focal shadowing\u002Finfiltrates on chest X-ray or CT-scan\n   * AND at least one of the following: cough, purulent sputum, chest pain or dyspnoea\n5. Requirement of supplemental oxygen at a flow rate of at least 3L\u002Fmin OR non-invasive ventilation OR high flow oxygen therapy OR invasive mechanical ventilation\n6. Written informed or emergency consent\n7. Ongoing medical insurance\n\nExclusion Criteria:\n\n1. Moribund state\n2. Bone marrow transplant or chemotherapy-induced neutropenia\n3. Known allergy to dexamethasone or to one of its excipients\n4. Uncontrolled psychotic states\n5. Pheochromocytoma\n6. Co-infection with COVID-19\n7. Cardiogenic shock secondary to influenza myocarditis\n8. Known active tuberculosis or fungal infection\n9. Active viral hepatitis or active herpes virus infection\n10. Patient at risk of strongyloidiasis\n11. Subject with shock on enrolment and on ongoing vasopressor therapy (≥ 0.25 microg\u002Fkg\u002Fmin)\n12. Indication for corticosteroid therapy in a dosage above 0.5mg\u002Fkg\u002Fday prednisone-equivalent\n13. Subject deprived of liberty or under a legal protective measure (example: patients under guardianship or curatorship)\n14. Pregnant or breastfeeding woman\n15. Lack of clinical equipoise by the attending physician and\u002For the presence of a substantial risk associated with the patients' participation in the trial","ALL","18 Years",{"count":692,"type":693},544,"ESTIMATED","INTERVENTIONAL",[696],"PHASE3","This is a Phase III, multicentre, randomized, controlled, double-blind, superiority trial aiming to evaluate the efficacy of dexamethasone versus placebo in patients admitted to intensive care or intermediate care with influenza and hypoxemic acute respiratory failure. Patients will receive state-of-the-art standard therapy for severe influenza. They will be randomized in a 1:1 ratio to one of the two arms. Patients, investigators and care providers will be blinded to the patient arm. Patients will receive antiviral treatment and antibiotic therapy if bacterial co-infection is suspected. All clinical interventions such as use of ventilatory strategy, laboratory tests, and hemodynamic management will be left at the discretion of the team in both arms. Special attention will be given to the prompt diagnosis and management of aspergillosis, with investigators provided with decision support tools and algorithms based on the most recent definition (i.e., FUNDICU). Patients will be followed for up to 28 days after enrolment and national registries will be used for 90-day vital status assessment. Telephone calls will be made on day 90 to assess quality of life.",[699,700,701,702,703],"Severe Influenza","Intensive Care (ICU)","Reanimation","Infectious Diseases","Hygiene",[699,705,706,707],"corticosteroids","acute respiratory distress syndrome","intensive care unit","NOT_YET_RECRUITING","2026-08-26",{"date":711,"type":712},"2026-08-28","ACTUAL",{"date":714,"type":693},"2026-09",{"date":716,"type":693},"2029-12",{"name":5,"class":6},48]