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

Chulalongkorn University

Status: Enrolling

Conditions: Severe Dengue

Treatments: Drug: Placebo; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05631405

IRB.436/65

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 7 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Intervention

Experimental group

Treatment:

Drug: Dexamethasone