Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (isHLH) (isHLH-IVD/IVIg)
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)
Rationale/Gaps 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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Deba Prasad Dhibar, MD
- 電話番号：+911722756670
- メール：drdeba_prasad@yahoo.co.in
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥ 18 years
- Gender: Male/female
- h-Score probability ≥ 80%
- Known microbiological etiology
- Mild HLH not responding to infection specific targeted antimicrobial therapy (> 72 hours)
- Mild HLH developing new organ dysfunction
- Moderate to severe HLH with life threatening organ dysfunction
Exclusion Criteria:
- Primary (familial) HLH
- Malignancy associated HLH
- HLH associated with autoimmune disease
- EBV associated HLH
- Pregnancy
- Receiving immune modulator therapy within 2 moths
- Participants with HIV
- Consent not given
- Known hypersensitivity to IVIG or Dexamethasone
- Chronic liver disease
- Chronic kidney disease
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：IVIg
Will receive intravenous Immunoglobulin (IVIg) therapy |
Injection IVIg (400 mg/kg Body weight) over an hour IV infusion X 5 days (total cumulative dose 2g/kg). Infection specific targeted antimicrobial therapy along with standard medical care |
|
実験的：IVD
Will receive intravenous Dexamethasone (IVD) |
Infection specific targeted antimicrobial therapy along with standard medical care Injection Dexamethasone (10mg/m2) in 100 ml 0.9% normal saline (NS) over half an hour IV infusion X 3 days |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical remission
時間枠：4 weeks
|
Number of participants become persistently asymptomatic without fever for ≥72 hours with h-Score probability <80% and without any HLH-related new organ dysfunction at 1 week and 4 weeks of the IVIG/IVD intervention |
4 weeks
|
|
The recovery of HLH-associated cytokines
時間枠：4 weeks
|
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/IVD intervention |
4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recovery of the hematological parameters
時間枠：4 weeks
|
Number of participants with recovery or normalization of the hematological parameters (hemoglobin, total leukocyte count, and platelet count) |
4 weeks
|
|
Adverse events/ adverse drug reactions
時間枠：4 weeks
|
Number of incidence of any adverse events and adverse drug reactions |
4 weeks
|
|
Duration of hospital stay
時間枠：4 weeks
|
Number of days of hospital admission |
4 weeks
|
|
Incidence of relapse of HLH: Recurrence of HLH after achieving clinical remission
時間枠：4 weeks
|
Number of participants having recurrence of HLH after achieving clinical remission |
4 weeks
|
協力者と研究者
捜査官
- 主任研究者：Deba Prasad Dhibar, MD、Post Graduate Institute of Medical Education and Research, Chandigarh, India
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PGI/IEC/2026/SPL-1447
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All the reasonable data requests should be submitted to the principal investigator (DPD) for consideration.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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