Temporal cytokine storm dynamics in dengue infection predicts severity.
Puneet Bhatt, Muralidhar Varma, Vikas Sood...
https://pubmed.ncbi.nlm.nih.gov/38176525Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06751836
Advancing Pandemic Preparedness: Innovative Multidisciplinary Strategies for COMBATing Severe Dengue
Led by Karolinska Institutet · Updated on 2025-02-10
1400
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
B
BIO BOX GUATEMALA ONG DE INVESTIGACIÓN, SERVICIOS Y DE MEDIO AMBIENTE
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating biomarkers and host factors linked to dengue severity in patients from regions where dengue is common. The study aims to determine if multi-omics techniques can predict disease severity and identify key factors involved in severe dengue infections. This observational research focuses on understanding how dengue virus manipulates host metabolism and immune responses to better predict disease progression and find new treatment targets. Participants include individuals with dengue infection classified by severity: dengue without warning signs, dengue with warning signs, severe dengue, and a group of healthy controls. Blood samples will be collected at hospitalization and discharge and analyzed using transcriptomics, proteomics, and metabolomics. The study includes discovery cohorts from Guatemala and validation cohorts from India, aiming to explore viral serotypes, host cytokine profiles, and cellular pathways involved in disease severity. During the study, participants will provide blood samples for detailed laboratory analysis. Researchers will measure biomarkers to understand immune responses and disease mechanisms. The primary outcome is discovering predictive biomarkers and developing an AI tool for dengue severity, monitored from enrollment until two weeks after hospitalization. The study also involves matching controls for age and gender, with careful screening to exclude recent dengue infections.
CONDITIONS
Brief Title
Innovative Multidisciplinary Strategies for Combating Severe Dengue
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Laboratory-confirmed dengue infection by anti-dengue IgM or NS1 ELISA
- For dengue without warning signs: fever plus at least two symptoms such as muscle or joint pain, nausea, vomiting, rash, or low white blood cell count
- For dengue with warning signs: above symptoms plus clinical signs like abdominal pain, persistent vomiting, fluid buildup, mucosal bleeding, lethargy, liver enlargement over 2cm, increased hematocrit and decreased platelets
- For severe dengue: severe plasma leakage causing shock or fluid buildup with respiratory distress, severe bleeding, or organ failure including liver enzyme elevation or impaired consciousness
- Healthy controls must have tested negative for dengue infection in the past three months and be age- and gender-matched to cases
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and blood sample collection
Diagnostic Evaluation
Duration - Up to 1 day
Participants with suspected dengue infection undergo laboratory confirmation and classification into severity groups based on clinical signs and laboratory tests.
1 visit (in-person) for blood sample collection on the day of hospitalization
Monitoring
Duration - Up to 2 weeks or until discharge
Participants are monitored during hospitalization to evaluate disease progression and clinical severity.
2 blood sample collections: one on the day of hospitalization and one on the day of discharge
Trial Site Locations
Total: 2 locations
1
Bio Box Guatemala Ong de Investigación, Servicios Y de Medio Ambiente
Guatemala City, Guatemala
Actively Recruiting
2
Manipal Academy of Higher Education (MAHE)
Mangalore, Karnataka, India, 576104
Actively Recruiting
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Research Team
U
Ujjwal Neogi, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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