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

Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05631405
Enrollment
200
Registered
2022-11-30
Start date
2022-10-16
Completion date
2027-12-31
Last updated
2026-06-16

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

Conditions

Severe Dengue

Keywords

Severe Dengue, Dexamethasone, Steroid

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.

Interventions

DRUGDexamethasone

Patients treated with dexamethasone

DRUGPlacebo

Patients treated with placebo

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality28 daysThe use of steroids in dengue will reduce mortality in rate

Secondary

MeasureTime frameDescription
Length of hospital stay28 daysThe use of steroids in dengue will reduce Length of hospital stay in day

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026