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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05631405
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 26.5
• Patients Per Site: 100
• Patients Per Site Per Month: 3.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Dengue	Drug: Dexamethasone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone
• Actual Study Start Date: Oct 16, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Dexamethasone; Patients treated with dexamethasone
Experimental: Intervention	Drug: Dexamethasone; Patients treated with dexamethasone

Outcome Measures

Primary Outcome Measures

1. Mortality [28 days]

   The use of steroids in dengue will reduce mortality in rate

Secondary Outcome Measures

1. Length of hospital stay [28 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chulalongkorn University	Bangkok		Thailand
2	King Chulalongkorn Memorial Hospital	Bangkok		Thailand

Sponsors and Collaborators

• Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nattachai Srisawat ,M.D., Assoc.Prof.Nattachai Srisawat, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT05631405
• Other Study ID Numbers: IRB.436/65
• First Posted: Nov 30, 2022
• Last Update Posted: Nov 30, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nattachai Srisawat ,M.D., Assoc.Prof.Nattachai Srisawat, Chulalongkorn University: Severe Dengue; Dexamethasone; Steroid
• Additional relevant MeSH terms: Dengue; Severe Dengue; Dexamethasone

Study Results

No Results Posted as of Nov 30, 2022