[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659214":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":38,"interventions":52,"overallOfficials":66,"centralContacts":71,"locations":29,"responsibleParty":76,"collaborators":79,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":29,"enrollmentInfo":93,"targetDuration":29,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":108,"whyStopped":29,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":29},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Clinical remission","Number of participants become persistently asymptomatic without fever for ≥72 hours with h-Score probability \\\u003C80% and without any HLH-related new organ dysfunction at 1 week and 4 weeks of the IVIG\u002FIVD intervention","4 weeks",{"measure":14,"description":15,"timeFrame":12},"The recovery of HLH-associated cytokines","Number of participants having reduction of HLH-associated cytokines (IL-1, IL-6, TNF-α, IFN-γ, GM-CSF) and Ferritin level from the pre-intervention baseline at 1 week and 4 weeks of the IVIG\u002FIVD intervention",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Recovery of the hematological parameters","Number of participants with recovery or normalization of the hematological parameters (hemoglobin, total leukocyte count, and platelet count)",{"measure":21,"description":22,"timeFrame":12},"Adverse events\u002F adverse drug reactions","Number of incidence of any adverse events and adverse drug reactions",{"measure":24,"description":25,"timeFrame":12},"Duration of hospital stay","Number of days of hospital admission",{"measure":27,"description":28,"timeFrame":12},"Incidence of relapse of HLH: Recurrence of HLH after achieving clinical remission","Number of participants having recurrence of HLH after achieving clinical remission",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","Randomized controlled open-label clinical trial","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":29},"NONE","The outcome assessor",[39,46],{"label":40,"type":41,"description":42,"interventionNames":43},"IVIg","ACTIVE_COMPARATOR","Will receive intravenous Immunoglobulin (IVIg) therapy",[44,45],"Drug: Intravenous Immunoglobulin (IVIg) therapy","Drug: Targeted antimicrobial therapy & standard care",{"label":47,"type":48,"description":49,"interventionNames":50},"IVD","EXPERIMENTAL","Will receive intravenous Dexamethasone (IVD)",[51,45],"Drug: Intravenous Dexamethasone (IVD) therapy",[53,58,62],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":29},"DRUG","Intravenous Immunoglobulin (IVIg) therapy","Injection IVIg (400 mg\u002Fkg Body weight) over an hour IV infusion X 5 days (total cumulative dose 2g\u002Fkg).",[40],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":29},"Intravenous Dexamethasone (IVD) therapy","Injection Dexamethasone (10mg\u002Fm2) in 100 ml 0.9% normal saline (NS) over half an hour IV infusion X 3 days",[47],{"type":54,"name":63,"description":64,"armGroupLabels":65,"otherNames":29},"Targeted antimicrobial therapy & standard care","Infection specific targeted antimicrobial therapy along with standard medical care",[47,40],[67],{"name":68,"affiliation":69,"role":70},"Deba Prasad Dhibar, MD","Post Graduate Institute of Medical Education and Research, Chandigarh, India","PRINCIPAL_INVESTIGATOR",[72],{"name":68,"role":73,"phone":74,"phoneExt":29,"email":75},"CONTACT","+911722756670","drdeba_prasad@yahoo.co.in",{"type":70,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Deba Prasad Dhibar","Principal investigator",[80],{"name":81,"class":82},"Indian Council of Medical Research","OTHER_GOV","100659214","phase-3-efficacy-of-short-course-of-intravenous-dexamethasone-and-intravenous-immunoglobulin-therapy-in-infection-related-secondary-hemophagocytic-lymphohistiocytosis-ishlh-100659214",false,"NCT07861776","Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (isHLH)","Randomized Controlled Trial to Evaluate and Compare the Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (sHLH)","isHLH-IVD\u002FIVIg","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Gender: Male\u002Ffemale\n* h-Score probability ≥ 80%\n* Known microbiological etiology\n* Mild HLH not responding to infection specific targeted antimicrobial therapy (\\> 72 hours)\n* Mild HLH developing new organ dysfunction\n* Moderate to severe HLH with life threatening organ dysfunction\n\nExclusion Criteria:\n\n* Primary (familial) HLH\n* Malignancy associated HLH\n* HLH associated with autoimmune disease\n* EBV associated HLH\n* Pregnancy\n* Receiving immune modulator therapy within 2 moths\n* Participants with HIV\n* Consent not given\n* Known hypersensitivity to IVIG or Dexamethasone\n* Chronic liver disease\n* Chronic kidney disease","ALL","18 Years",{"count":94,"type":95},116,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","Rationale\u002FGaps in Existing Knowledge: Therapy of Infection-associated Secondary Hemophagocytic lymphohistiocytosis (sHLH) in adult lacks evidence from randomized trial guiding first-line immunomodulation and current therapeutic practice primarily extrapolated from decades old pediatric HLH protocols and retrospective studies. In presence of infection very expensive therapy with intravenous Immunoglobulin (IVIG) is preferred over Dexamethasone, however the comparative efficacy of IVIG and Dexamethasone alone remains undefined, especially in resource-constraints settings. (ii) Novelty: This will be among the first randomized controlled trials in adults with infection-associated sHLH, directly comparing efficacy of IVIG with Dexamethasone. The study uniquely integrates clinical outcomes with economic feasibility in a low-middle income setting. (iii) Objectives: Primary objectives will be to compare the efficacy of intravenous (IV) Dexamethasone and IVIG in achieving clinical remission and recovery of HLH-associated cytokines (IL-1, IL-6, TNF-α, IFN-γ, GM-CSF) and Ferritin level. Secondary objectives include assessment of hematologic recovery, adverse events, and short-term mortality. (iv)Method: In this Randomized controlled open-label, non-inferiority clinical trial participants with sHLH, will be allocated (1:1) to receive either short-course of IV Dexamethasone or IVIG along with infection-directed standard care and will be followed-up for 4 weeks to evaluate predefined clinical outcome and laboratory parameters. (v) Expected Outcome: The study aims to establish whether IV Dexamethasone is non-inferior to IVIG for achieving clinical remission, recovery of HLH-associated cytokines level and reduction of short-term mortality. Results are expected to reform evidence-based, cost-effective therapeutic strategies for infection-associated sHLH and improve access to care in resource-constraint healthcare systems.",[101,102],"Hemophagocytic Lymphohistiocytosis (HLH)","Secondary Hemophagocytic Lymphohistiocytosis",[104,105,106,107],"Hemophagocytic lymphohistiocytosis (HLH)","Dexamethasone","Intravenous Immunoglobulin (IVIg)","Infection associated secondary HLH (isHLH)","NOT_YET_RECRUITING","2026-10-01",{"date":111,"type":112},"2026-10-06","ACTUAL",{"date":114,"type":95},"2026-10-15",{"date":116,"type":95},"2029-09-30",{"name":5,"class":6}]