Immune Responses to Dengue and Sepsis

Recruiting now

Conditions studied: Dengue, Sepsis

In brief

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.

Key facts

Study ID

NCT07040202

Run by

Institut Pasteur du Cambodge

People needed

240

Starts

2025-06-02

Expected to finish

2026-12-01

Last updated by the study team

2025-06-27

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with dengue-like illness:
• Patients presenting with dengue-like symptoms for a duration of maximum 72h before inclusion. Dengue-like symptoms include: presentation with oral temperature >38°C AND at least two of the following symptoms suggestive of dengue-like illness: headache, retro-orbital pain, myalgia, joint pain, rash, any bleeding symptoms, nausea or vomiting, lethargy or restlessness , abdominal pain, liver enlargement
• Sepsis patients:
• Patients admitted for less than 48 hours with a primary diagnosis of sepsis as per treating team AND have blood cultures ordered AND on empiric antibiotics due to concern for bacterial infection.
• Healthy controls:
• Participants with no chronic illness, no regular medications, no febrile illness in 28 days, no diagnosis of or treatment for dengue or bacterial infection in the past 6 months.

You may not qualify if…

• For biobanking purposes, children less than 2 years of age, and individuals who are pregnant, pregnant within the last 90 days, and/or breastfeeding are excluded due to restrictions on the blood volumes and the repeated sampling times.
• Individuals that do not provide informed consent will not be included for the study.
• Severe/chronic/recurrent pathological conditions: clinically significant autoimmune disease or immunodeficiency (including history of organ transplant), haematologic disorders, cardiac diseases, diabetes, cancer, HIV, chronic hepatic or renal insufficiency.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the inclusion. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for > 2 weeks (inhaled and topical steroids allowed)
• Chronic administration of NSAIDs, including aspirin: prolonged intake (>2 weeks) within 6 months before study or any intake within the 7 days preceding sampling [exception for low dose aspirin: maximum 250mg/daily]
• Any underlying, chronic, or current condition that, in the opinion of the investigator, may interfere with their participation in the study.
• Expected death in the next 48-hours

Where it is running

• Kampong Speu District Referral Hospital — Kampong Speu, Cambodia (enrolling)
• International Center of Excellence in Research Cambodia — Phnom Penh, Cambodia (enrolling)
• Preah Kossamak Hospital — Phnom Penh, Cambodia (enrolling)

Full record on ClinicalTrials.gov

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