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

NCT ID: NCT05631405

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-16

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Dengue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients treated with placebo

Intervention

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Patients treated with dexamethasone

Interventions

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Dexamethasone

Patients treated with dexamethasone

Intervention Type DRUG

Placebo

Patients treated with placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Nattachai Srisawat ,M.D.

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chulalongkorn University

Bangkok, , Thailand

Site Status RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Nattachai Srisawat

Role: primary

02-256-4000 ext. 3597

Sasipha Tachaboon

Role: primary

6622564000 ext. 3679

Other Identifiers

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IRB.436/65

Identifier Type: -

Identifier Source: org_study_id

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