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

Severe Dengue Clinical Trial

Official title:

Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631405
• Other study ID #: IRB.436/65
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dengue
• Severe Dengue

Intervention

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

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	The use of steroids in dengue will reduce mortality in rate	28 days
Secondary	Length of hospital stay	The use of steroids in dengue will reduce Length of hospital stay in day	28 days