An observational study in Dengue, Sepsis and Influenza, sponsored by Institut Pasteur du Cambodge. Recruiting at 4 sites in Cambodia. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Institut Pasteur du Cambodge · Observational
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.
This is an observational study enrolling n=200 hospitalized individuals with dengue-like illness, n=50 individuals with influenza, n=30 individuals with sepsis, and n\<=50 healthy controls to evaluate immune responses in syndromes that cause plasma leak and organ damage. Sepsis and dengue patients will have blood collected at enrollment, day 1, and day 3, and dengue patients will have an additional blood draw at day 21. Influenza patients will have a nasopharyngeal swab and blood collected at enrollment, and blood collected at days 3 and 21. Healthy participants will have a single blood draw at enrollment. The blood collected will enable the evaluation of immune kinetics, including changes in neutrophils, cytokines, and adaptive responses, as dengue progresses or improves. Overall, this study will facilitate the evaluation of an understudied cell type and will provide unique data for understanding the temporal changes in the immune response to dengue virus. A better understanding of dengue pathophysiology will help identify potential therapeutic targets to improve outcomes in this disease.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 240 is below the median of 595 across 80 observational studies indexed under Dengue.
Browse Dengue studies →Institut Pasteur du Cambodge is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be enrolled from Kampong Speu District Referral Hospital (Kampong Speu), Preah Kossamak Hospital (Phnom Penh), National Pediatric Hospital (Phnom Penh), and the International Center of Excellence in Research Cambodia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Patients 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.
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.
Time frame: From enrollment to study day 3
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.
Time frame: From enrollment to study day 3.
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.
Time frame: Enrollment to study day 3
Percentage of low density neutrophils in dengue versus sepsis versus influenza.
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 versus influenza.
Time frame: From enrollment to study day 3
Mean florescence intensity of neutrophils expressing spleen tyrosine kinase in dengue versus sepsis versus influenza.
Mean florescence intensity (MFI) of neutrophils expressing spleen tyrosine kinase will be measured via flow cytometry and compared between those with dengue versus sepsis versus influenza. Other markers of neutrophil maturation, activation, and degranulation will be measured by flow cytometry and compared among dengue groups and between dengue and sepsis and influenza.
Time frame: From enrollment to study day 3.
Serum level of myeloperoxidase in dengue versus sepsis versus influenza
Serum level of myeloperoxidase will be measured in pg/mL and compared between participants with dengue versus sepsis versus influenza. Other biomarkers of neutrophil activation such as calprotectin, resistin, and lactoferrin will be measured and compared among groups.
Time frame: Enrollment to study day 3
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, influenza, and sepsis overtime. Other cytokines may also be measured and compared among groups.
Time frame: Enrollment through day 3.
Percentage of DENV-specific activated T cells
Activation induced marker assays will be used to compare dengue virus (DENV)-specific T cell activation over time in mild/moderate versus severe dengue.
Time frame: Enrollment through day 21.
DENV1-4 geometric mean titer (GMT)
DENV1-4 GMT overtime will be compared between mild/moderate and severe dengue groups. These will also be correlated with disease outcome and GMT at convalescence.
Time frame: Enrollment to day 21
Peak dengue virus enhancing titer
Peak dengue virus enhancing titer overtime will be compared between mild/moderate and severe dengue groups. These will also be correlated with disease outcome and GMT at convalescence.
Time frame: Enrollment to day 21
Mean fluorescence intensity of specific lymphocyte populations among groups
Mean fluorescence intensity of specific lymphocyte populations will be compared mild/moderate versus severe dengue and dengue versus sepsis.
Time frame: Enrollment to day 3
Number of differentially expressed genes among groups
The number of differentially expressed genes will be compared between mild/moderate and severe dengue and dengue versus sepsis versus influenza based on thresholds for statistical significance (e.g., adjusted p-value \< 0.05) and magnitude of change (e.g., absolute log2 fold change \> 1).
Time frame: Enrollment to day 3
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Institut Pasteur du Cambodge