Immune responses in dengue and sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort enrolls about 200 hospitalized patients with dengue-like illness, 30 patients with sepsis, and 10 healthy controls at sites in Cambodia. Blood samples are taken at enrollment, day 1 and day 3 for sepsis and dengue patients, with an additional day 21 draw for dengue patients, while healthy controls give one enrollment sample. Multiple laboratory analyses will track immune kinetics including neutrophils, cytokines, and adaptive immune responses and will examine an understudied immune cell type. Comparing dengue, sepsis, and healthy profiles over time aims to clarify temporal changes in immune response during plasma leak syndromes and recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

\- Influenza patients: Patients presenting with with oral temperature \>38°C and cough that started within the last 4 days AND rapid test or PCR positive for influenza infection AND no COVID-19 or positive bacterial cultures at the time of enrollment.

* 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.

Exclusion Criteria:

* 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's running

• Kampong Speu District Referral Hospital
  Kampong Speu, Cambodia Recruiting
• International Center of Excellence in Research Cambodia
  Phnom Penh, Cambodia Recruiting
• National Pediatric Hospital
  Phnom Penh, Cambodia Recruiting
• Preah Kossamak Hospital
  Phnom Penh, Cambodia Recruiting

Study contacts

• Principal investigator: Tineke Cantaert, PhD — Institut Pasteur du Cambodge
• Study coordinator: Chanthap Lon, MD
• Email: lonc@icercambodia.org
• Phone: +855 12976 799

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.