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

Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Dengue
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • King Chulalongkorn Memorial Hospital
    • Contact: Sasipha Tachaboon; Phone Number: 3679 6622564000; Email: sasipha_tac@hotmail.com
  • Bangkok, Thailand
    • Recruiting
    • Chulalongkorn University
    • Contact: Nattachai Srisawat; Phone Number: 3597 02-256-4000; Email: drnattachai@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Patients treated with placebo
Experimental: Intervention	Drug: Dexamethasone; Patients treated with dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The use of steroids in dengue will reduce mortality in rate	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	The use of steroids in dengue will reduce Length of hospital stay in day	28 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Dexamethasone; Steroid; Severe Dengue
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue; Severe Dengue; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: IRB.436/65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No