Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT07040202
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
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT07040202
Study Brief:
Protocol Section:
NCT07040202