Actively Recruiting
Evaluating Immune Responses to Dengue and Sepsis in Hospitalized Patients in Cambodia
Led by Institut Pasteur du Cambodge · Updated on 2025-06-27
240
Participants Needed
3
Research Sites
56 weeks
Total Duration
On this page
Sponsors
I
Institut Pasteur du Cambodge
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating immune responses in people with serious dengue disease, sepsis, and healthy individuals to better understand how these conditions affect the body's defenses. This observational study will enroll 200 hospitalized patients with dengue-like illness, 30 with sepsis, and 10 healthy controls to compare immune system activity, focusing on plasma leak syndromes and specific immune cells over time. Participants with dengue or sepsis will have blood samples collected at enrollment, day 1, and day 3, with dengue patients also having a sample taken at day 21. Healthy participants will provide one blood sample at enrollment. These samples will be analyzed for immune changes such as neutrophil behavior, cytokine levels, and adaptive immune responses as the diseases progress or improve. During the study, participants will provide clinical information and blood samples according to their group. Researchers will measure immune cell activity, gene expression, and serum markers to track disease progression and differences between dengue and sepsis. The study aims to identify key immune changes that could inform future treatments. Participation involves hospital visits up to 21 days with repeated blood draws, and the study will continue until December 2026.
CONDITIONS
Brief Title
Immune Responses to Dengue and Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with dengue-like illness presenting with fever over 38°C and at least two symptoms such as headache, muscle pain, rash, bleeding, nausea, lethargy, abdominal pain, or liver enlargement, with symptoms starting within 72 hours before enrollment.
- Patients admitted less than 48 hours ago with a primary diagnosis of sepsis, blood cultures ordered, and receiving antibiotics for suspected bacterial infection.
- Healthy participants with no chronic illness, no regular medications, no fever in the past 28 days, and no diagnosis or treatment for dengue or bacterial infection in the past 6 months.
- Age 2 years or older.
You will not qualify if you...
- Children under 2 years old, pregnant, recently pregnant within 90 days, or breastfeeding individuals.
- Individuals who do not provide informed consent.
- Those with severe or chronic diseases including autoimmune disorders, immunodeficiency, organ transplant history, blood disorders, heart disease, diabetes, cancer, HIV, or chronic liver or kidney failure.
- Use of immunosuppressant or immune-modifying drugs for more than 14 days in the past 6 months, including corticosteroids at doses equivalent to 20 mg/day prednisone or higher.
- Prolonged use of NSAIDs or aspirin longer than 2 weeks in the past 6 months, or any use within 7 days before sampling except low-dose aspirin up to 250 mg daily.
- Any condition that the investigator believes may interfere with study participation.
- Expected death within 48 hours.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have blood collected at enrollment to evaluate immune responses in dengue, sepsis, or healthy controls.
1 visit (in-person)
Duration - 3 days
Participants with dengue-like illness or sepsis have additional blood draws on days 1 and 3 to monitor immune response changes.
2 visits (in-person)
Duration - Up to 21 days
Dengue patients have a final blood draw on day 21 to assess immune response progression.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
Kampong Speu District Referral Hospital
Kampong Speu, Cambodia
Actively Recruiting
2
International Center of Excellence in Research Cambodia
Phnom Penh, Cambodia
Actively Recruiting
3
Preah Kossamak Hospital
Phnom Penh, Cambodia
Actively Recruiting
Research Team
C
Chanthap Lon, MD
C
Camila D Odio, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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