[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hygiene\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hygiene":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":20,"type":21},544,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Severe Influenza","Intensive Care (ICU)","Reanimation","Infectious Diseases","Hygiene",[27,33,34,35],"corticosteroids","acute respiratory distress syndrome","intensive care unit","NOT_YET_RECRUITING","2026-08-26",{"date":39,"type":40},"2026-08-28","ACTUAL",{"date":42,"type":21},"2026-09",{"date":44,"type":21},"2029-12",{"name":46,"class":47},"Centre Hospitalier Régional Metz-Thionville","OTHER",48]