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Feasibility parallel-group randomized controlled trial with the intervention of corticosteroids in hospitalised participants with Dengue

Protocol for a seamless phase2-3 parallel group randomized controlled trial of corticosteroids in dengue - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076811
Enrollment
100
Registered
2024-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A90- Dengue fever [classical dengue]

Interventions

Intervention1: Dexamethasone: 0.1mg IV once daily for a maximum of 5 days or until death or discharge (whichever is earlier) Intervention2: Dexamethasone: 0.2mg once daily for a maximum of 5 days or

Sponsors

George Institute for Global Health, Australia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eligible participants are adult (more than18yrs) patients admitted to the hospital with dengue and meeting one of the following criteria 1. Evidence of fluid leak in the form of raised hematocrit or presence of pleural effusion or ascites (detected using bedside ultrasonography) 2. Presence of thrombocytopenia (platelet count less than 150000) 3. Any evidence of organ dysfunction in the form of altered consciousness, need for O2 supplementation or need for non-invasive or invasive ventilation, vasopressors or kidney replacement therapy 4. Evidence of liver injury (AST or ALT levels ?5 times the upper limit of normal)

Exclusion criteria

Exclusion criteria: 1. 1.Already on long-term steroid treatment for more than 4 weeks. 2.Patients who are expected to die within the next 24 hrs. 3.Patients with the presence of an advanced directive for non-initiation of organ support 4.Duration from hospital admission more than 72hrs 5.Active tuberculosis or invasive fungal infection at the time of enrolment

Design outcomes

Primary

MeasureTime frame
Primary outcome related to feasibility consent rate adherence to protocol adverse event profiles Timepoint: Day7 Day 28 Day 90

Secondary

MeasureTime frame
Days alive and free of hospital until D90 Days alive and free or organ support until D28 Hospital and ICU length of stay Mean change from baseline in platelets count Timepoint: Day 4 and 7 Day 28 and 90

Countries

India

Contacts

Public ContactShani S Thankachen

Apollo Hospital ,Chennai

bharath@icuconsultants.com919591100655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026