About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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)
Trial population
Patients will be enrolled from Kampong Speu District Referral Hospital (Kampong Speu), Preah Kossamak Hospital (Phnom Penh), and the International Center of Excellence in Research Cambodia.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Percentage of low density neutrophils in mild/moderate vs severe dengue
Low density neutrophils will be isolated from the PBMC layer of centrifuged blood and characterized via flow cytometry. The percentages of low density neutrophils will be compared between dengue groups.
Mean florescence intensity of neutrophils expressing spleen tyrosine kinase
The mean florescence intensity (MFI) of neutrophils expressing spleen tyrosine kinase will be measured via flow cytometry and compared between mild/moderate vs severe dengue.
Serum level of myeloperoxidase in mild/moderate versus severe dengue.
The serum level of myeloperoxidase will be measured in pg/mL and compared between participants with mild/moderate versus severe dengue.
Secondary outcomes
Percentage of low density neutrophils in dengue versus sepsis
Low density neutrophils will be isolated from the PBMC layer of centrifuged blood and characterized via flow cytometry. The percentage of low density neutrophils will be compared in dengue versus sepsis.
Mean florescence intensity of neutrophils expressing spleen tyrosine kinase in dengue versus sepsis
Mean florescence intensity (MFI) of neutrophils expressing spleen tyrosine kinase will be measured via flow cytometry and compared between those with dengue versus sepsis. Other markers of neutrophil maturation, activation, and degranulation will be measured by flow cytometry and compared among dengue groups and between dengue and sepsis.
Serum level of myeloperoxidase in dengue versus sepsis
Serum level of myeloperoxidase will be measured in pg/mL and compared between participants with dengue versus sepsis. Other biomarkers of neutrophil activation such as calprotectin, resistin, and lactoferrin will be measured and compared among groups.
Serum levels of interferon-gamma and interleukin-10 (pg/mL)
Serum levels of interferon-gamma and interleukin-10 (pg/mL) will be measured and compared between dengue groups and sepsis overtime. Other cytokines may also be measured and compared among groups.
Sponsors and contacts
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Institut Pasteur du Cambodge
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator