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

ConditionSevere Dengue

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-99

SponsorChulalongkorn University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe dengue> 24 hrs

Dengue without warning signs

Pregnancy

Patient who receieved any steroid within 1 week

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mortality

The use of steroids in dengue will reduce mortality in rate

Time frame

28 days

Secondary outcomes

Length of hospital stay

The use of steroids in dengue will reduce Length of hospital stay in day

Time frame

28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov

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