Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (isHLH)

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Rationale/Gaps in Existing Knowledge: Therapy of Infection-associated Secondary Hemophagocytic lymphohistiocytosis (sHLH) in adult lacks evidence from randomized?randomized Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable. 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?adverse events Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome., and short-term mortality. (iv)Method: In this Randomized controlled open-label?open-label No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff., non-inferiority?non-inferiority What a comparison is designed to show. A superiority study asks whether the new treatment is better than the comparator; a non-inferiority study asks whether it is not meaningfully worse. clinical trial?clinical trial A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects. participants with sHLH, will be allocated (1:1?1:1 How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.) 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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.