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NCT07040202From ClinicalTrials.govRecruiting

Immune Responses to Dengue and Sepsis

Evaluating Immune Responses to Dengue and Sepsis in Hospitalized Patients in Cambodia

  • Dengue
  • Sepsis
  • Influenza

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Institut Pasteur du Cambodge
Enrolment target
240
Started
2 June 2025
Main results due
July 2027
Study sites
4
Registry updated
23 September 2026

Can you take part?

  • Aged 2 years and over.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

\- 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

What this study is about

In the sponsor’s own words, from the registry.

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, influenza, sepsis, or healthy people. The investigators will perform multiple analyses on the blood samples and compare results between dengue patients and those with influenza or sepsis and healthy people.

Study sites(4)

  • 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

Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07040202. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Immune Responses to Dengue and Sepsis | Trialion