Immune responses in dengue and sepsis
Evaluating Immune Responses to Dengue and Sepsis in Hospitalized Patients in Cambodia
This project will collect blood from people hospitalized with dengue-like illness or sepsis and from healthy volunteers to see how their immune responses change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Institut Pasteur du Cambodge Academic / other |
| Drugs / interventions | prednisone |
| Locations | 3 sites (Kampong Speu and 2 other locations) |
| Trial ID | NCT07040202 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients presenting within 72 hours of dengue-like symptoms or patients admitted within 48 hours for suspected sepsis, as well as healthy volunteers without chronic illness or recent febrile infection.
Not a fit: People who are pregnant, younger than 2 years for biobanking, not hospitalized at the enrolling sites, or outside the short symptom-onset windows are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the study could reveal immune markers or targets that help predict severe dengue or guide new treatment strategies.
How similar studies have performed: Previous observational immunology studies have documented cytokine and cellular changes in dengue and sepsis, but direct early-timepoint comparisons and focus on the specified understudied cell type are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 this trial is running
Kampong Speu and 2 other locations
- Kampong Speu District Referral Hospital — Kampong Speu, Cambodia (Recruiting)
- International Center of Excellence in Research Cambodia — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.