[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631189":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":64,"collaborators":41,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":41,"enrollmentInfo":76,"targetDuration":41,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":91,"whyStopped":41,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early strategy","EXPERIMENTAL","Etoposide treatment will be administered within 12 hours of inclusion.",[13],"Drug: Etoposide (Early strategy)",{"label":15,"type":16,"description":17,"interventionNames":18},"Delayed strategy","ACTIVE_COMPARATOR","The need for etoposide treatment will be reassessed after 48 hours of management. If organ failure worsens or fails to improve (modified SOFA increase ≥1 point or stable), etoposide will be administered within 12 hours of reassessment. In cases of rapidly deteriorating clinical status with short-term life-threatening prognosis (defined as an increase of 6 or more points in modified SOFA score), patients may receive rescue treatment (before 48 hours) with etoposide at the discretion of the medical team managing the patient; in such cases, the Day-2 infusion will not be administered.",[19],"Drug: Etoposide (Delayed strategy)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Etoposide (Early strategy)","early strategy arm: patients will receive etoposide treatment within 12 hours of inclusion.",[9],[27],"Etoposide is used at a dose of 100 mg\u002Fm², administered via slow intravenous infusion over 30 to 60 minutes on Day 0 or Day 2 depending on the arm.",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Etoposide (Delayed strategy)","delayed strategy arm: patients will be reassessed 48 hours after inclusion. If there is persistence or deterioration of organ failures (similar or higher modified SOFA score), patients will receive etoposide treatment within 12 hours of this reassessment in the absence of formal contraindications. In cases of rapidly deteriorating clinical status with short-term life-threatening prognosis (defined as an increase of 6 or more points in modified SOFA score), patients may receive rescue treatment (before 48 hours) with etoposide at the discretion of the medical team managing the patient; in such cases, the Day-2 infusion will not be administered. This practice will be exceptional and documented, following consultation with the hotline if possible.",[15],[27],[34],{"name":35,"affiliation":5,"role":36},"Julien SCHMIDT, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+33 (0)1.48.95.52.41",null,"julien.schmidt@aphp.fr",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Stéphane Gaudry, MD, PhD","+33(0)1.48.95.22.81","stephane.gaudry@aphp.fr",[48],{"facility":49,"status":41,"city":50,"state":41,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Intensive Care Unit - Avicenne Hospital, Assistance Publique des Hôpitaux de Paris","Bobigny","93000","France","FR",{"type":55,"coordinates":56},"Point",[57,58],2.45012,48.90982,{"lat":58,"lon":57},[61,62],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":44,"role":39,"phone":63,"phoneExt":41,"email":46},"+33 (0)1.48.95.22.81",{"type":65,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100631189","phase-3-comparison-of-two-etoposide-initiation-strategies-for-severe-hemophagocytic-lymphohistiocytosis-100631189",false,"NCT07497438","Comparison of Two Etoposide Initiation Strategies for Severe Hemophagocytic Lymphohistiocytosis","Comparison of Two Etoposide Initiation Strategies for Severe Hemophagocytic Lymphohistiocytosis in Intensive Care: a Randomized Trial","TIC-TAC-SAM","Inclusion Criteria:\n\n* Adult patient\n* Confirmed diagnosis of HLH:\n\n  * Hscore ≥ 169\n  * Diagnosis of HLH established by the multidisciplinary team caring for the patient(A 24\u002F7 hotline will be available in case of diagnostic uncertainty: this will be the direct line to the on-call intensivist at Avicenne Hospital, who can contact the coordinating investigator as needed)\n* First episode of HLH\n* Admission to intensive care unit\n* Presence of one or more organ failures:\n\n  * Circulatory: mBP \\\u003C 65 mmHg with lactate \\> 2 mmol\u002FL, or treatment with catecholamines\n  * Respiratory: oxygen therapy \\> 6 L\u002Fmin or need for non-invasive ventilation, high-flow nasal cannula oxygen therapy, or invasive mechanical ventilation\n  * Renal: stage 2 or higher according to KDIGO criteria, defined by a creatinine increase ≥ 2 times baseline, or urine output \\\u003C 0.5 mL\u002Fkg\u002Fh for ≥ 12 hours, or initiation of renal replacement therapy\n  * Neurological: GCS ≤ 13\n\nExclusion Criteria:\n\n* Moribund patient with refractory distributive shock: multi-organ failure requiring noradrenaline \\> 2.5 µg\u002Fkg\u002Fmin and imminent risk of death.\n* Inability to administer etoposide within 12 hours.\n* Patient treated with etoposide prior to admission to the intensive care unit.\n* Hypersensitivity to etoposide or any of its excipients.\n* Hypersensitivity or contraindication to dexamethasone or any of its excipients, as described in the package insert for the dexamethasone specialty used in the trial and in the protocol.\n* Patient with a history of CAR-T cell therapy.\n* Patient developing HLH within 15 days following chemotherapy for cancer or hematologic malignancy.\n* Patient not covered by social security.\n* Patient under legal guardianship, tutelage, or curatorship.\n* Minor patient.\n* Pregnant women (positive βhCG), women for whom pregnancy has not been excluded (βhCG not performed in women of childbearing age), or lactating women.\n* Recent vaccination with a live attenuated vaccine.\n* Participation in another interventional research study.","ALL","18 Years",{"count":77,"type":78},176,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","Hemophagocytic lymphohistiocytosis (HLH) is an immune-mediated disorder characterized by hyperactivation of the immune system, leading to a cytokine storm responsible for organ failures. Consequently, patients with HLH often require intensive care management, where their short-term prognosis is compromised (1-month mortality: 30 to 40%).\n\nTherapeutic management is urgent and consists in treating associated pathologies and employing immunomodulatory therapy. Currently, there are no clear and consistent recommendations for guiding immunomodulatory treatment in HLH due to the lack of high-level evidence studies. Experts recommend corticosteroid therapy for mild forms, whereas etoposide is proposed for severe cases, especially those with organ failures. However, in clinical practice, its use in patients with multi-organ failure is not systematic due to concerns about potential severe side effects and uncertainty regarding the contribution of severe sepsis to the clinical and biological presentation. Consequently, initiation of etoposide is sometimes delayed.\n\nOur hypothesis is that early treatment of severe HLH associated with organ failure using etoposide could reduce organ failures associated with this syndrome. Therefore, we aim to compare two strategies for initiating etoposide in severe HLH in intensive care: an early strategy where etoposide is prescribed at the onset of HLH-related organ failure, and a delayed strategy where etoposide is prescribed only if there is unfavorable progression (or lack of improvement) after treating associated pathologies, associated with corticosteroid therapy.",[84],"Hemophagocytic Lymphohistiocytosis",[86,87,88,89,90],"Hemophagocytic lymphohistiocytosis","Etoposide","Intensive care unit","cytokine storm","organe failures","NOT_YET_RECRUITING","2026-04-20",{"date":94,"type":95},"2026-04-23","ACTUAL",{"date":97,"type":78},"2026-04",{"date":99,"type":78},"2030-02",{"name":5,"class":6},1]