Immune Responses to Dengue and Sepsis

NCT07040202 | Recruiting

• 2 other identifiers: 092 NECHRApproval number
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Dengue; Sepsis

Keywords

dengue; sepsis; observational; infection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Enrollment to study day 3

Secondary Outcomes (9)

• Percentage of low density neutrophils in dengue versus sepsis

  From enrollment to study day 3

• Mean florescence intensity of neutrophils expressing spleen tyrosine kinase in dengue versus sepsis

  From enrollment to study day 3.

• Serum level of myeloperoxidase in dengue versus sepsis

  Enrollment to study day 3

• Serum levels of interferon-gamma and interleukin-10 (pg/mL)

  Enrollment through day 3.

• Percentage of DENV-specific activated T cells

  Enrollment through day 21.

Study Arms (3)

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.

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Patients with dengue-like illness:
• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Institut Pasteur du Cambodge: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Dengue; Sepsis; Infections

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tineke Cantaert, PhD

  Institut Pasteur du Cambodge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chanthap Lon, MD

CONTACT

+855 12976 799; lonc@icercambodia.org

Camila D Odio, MD

CONTACT

camila.odio@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 27, 2025
• Study Start: June 2, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CA (3)