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Recruiting NCT05631405

Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (DengDex Study)

No phase Interventional Severe Dengue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone, Placebo.
Who it may be relevant to
Registry conditions: Severe Dengue. Basic parameters: 7 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone

Overview

The goal of this randomized double-blinded placebo-controlled trial is to learn about dexamethasone and the treatment of severe dengue population. The main question it aims to answer are steroid therapy may be effective in dengue.

Interventions

  • Drug Dexamethasone
    Patients treated with dexamethasone
  • Drug Placebo
    Patients treated with placebo

Primary outcome measures

  • Mortality [Time frame: 28 days]
Secondary outcome measures (1)
  • Length of hospital stay [Time frame: 28 days]

Eligibility criteria

Inclusion criteria

  • Laboratory confirmed Dengue infected patients (Positive NS1 Ag or anti-DENV IgM by Dengue Duo test)
  • And still in febrile phase (Body temp>37.5 C)
  • Shock : Sys<90mmHg or Narrow PP (<20mmHg) orTachycardia (pulse>100/min) with Hematocrit decreased ≥20 %
  • Fluid accumulation and respiratory distress
  • Severe bleeding
  • Severe organ involvement

Exclusion criteria

  • Severe dengue> 24 hrs
  • Dengue without warning signs
  • Pregnancy
  • Patient who receieved any steroid within 1 week

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Thailand · 2 centers
  • Chulalongkorn University — Bangkok
  • King Chulalongkorn Memorial Hospital — Bangkok

Identifiers

NCT: NCT05631405 · IRB.436/65

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗