Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-01 @ 12:12 AM
Study NCT ID:
NCT07040202
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Responses to Dengue and Sepsis
Sponsor:
Institut Pasteur du Cambodge
Organization:
Study Overview
Official Title:
Evaluating Immune Responses to Dengue and Sepsis in Hospitalized Patients in Cambodia
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEN-SEP
Brief Summary:
The goal of this research study is to help the investigators better understand serious dengue disease. The investigators will collect clinical information and up to four blood samples from participants with dengue, sepsis, or healthy people. The investigators will perform multiple analyses on the blood samples and compare results between dengue patients and those with sepsis and healthy people.
Detailed Description:
This is an observational study enrolling n=200 hospitalized individuals with dengue-like illness, n=30 individuals with sepsis, and n=10 healthy controls to evaluate immune responses in plasma leak syndromes. Sepsis and dengue patients will have blood collected at enrollment, day 1, and day 3, and dengue patients will have an additional blood draw at day 21. Healthy participants will have a single blood draw at enrollment. The blood collected will enable the evaluation of immune kinetics, including changes in neutrophils, cytokines, and adaptive responses, as dengue progresses or improves. Overall, this study will facilitate the evaluation of an understudied cell type and will provide unique data for understanding the temporal changes in the immune response to dengue virus. A better understanding of dengue pathophysiology will help identify potential therapeutic targets to improve outcomes in this disease.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Approval number | OTHER | National Ethics Committee for Health Research Cambodia | View |