NCT05631405

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Oct 2022Dec 2026

Study Start

First participant enrolled

October 16, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

3.2 years

First QC Date

November 9, 2022

Last Update Submit

August 4, 2025

Conditions

Severe Dengue

Keywords

Severe DengueDexamethasoneSteroid

Outcome Measures

Primary Outcomes (1)

  • Mortality

    The use of steroids in dengue will reduce mortality in rate

    28 days

Secondary Outcomes (1)

  • Length of hospital stay

    28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Intervention

EXPERIMENTAL
Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Patients treated with dexamethasone

Intervention
PlaceboDRUG

Patients treated with placebo

Placebo

Eligibility Criteria

Age7 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chulalongkorn University

Bangkok, Thailand

RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Severe Dengue

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

DengueMosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 30, 2022

Study Start

October 16, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)