Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (DengDex Study)
Primary Purpose
Severe Dengue
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Severe Dengue focused on measuring Severe Dengue, Dexamethasone, Steroid
Eligibility Criteria
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
Sites / Locations
- Chulalongkorn UniversityRecruiting
- King Chulalongkorn Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Mortality
The use of steroids in dengue will reduce mortality in rate
Secondary Outcome Measures
Length of hospital stay
The use of steroids in dengue will reduce Length of hospital stay in day
Full Information
NCT ID
NCT05631405
First Posted
November 9, 2022
Last Updated
May 21, 2023
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT05631405
Brief Title
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (DengDex Study)
Official Title
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Dengue
Keywords
Severe Dengue, Dexamethasone, Steroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients treated with dexamethasone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients treated with placebo
Primary Outcome Measure Information:
Title
Mortality
Description
The use of steroids in dengue will reduce mortality in rate
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
The use of steroids in dengue will reduce Length of hospital stay in day
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nattachai Srisawat
Phone
02-256-4000
Ext
3597
Email
drnattachai@yahoo.com
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasipha Tachaboon
Phone
6622564000
Ext
3679
Email
sasipha_tac@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (DengDex Study)
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