Advancing Pandemic Preparedness: Innovative Multidisciplinary Strategies for COMBATing Severe Dengue

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The goal of this observational study is to identify biomarkers and host factors associated with dengue severity in patients from dengue-endemic regions. The main question it aims to answer is: Can multi-omics approaches predict disease severity and identify key factors contributing to severe dengue infections? Participants will include individuals with dengue infection, and the study will analyze their blood samples using multi-omics techniques to uncover host immune responses, disease pathogenesis, and cellular pathway interactions. The study will also assess the role of primary and secondary infections, virus serotypes, and immunological factors in disease progression. Findings aim to support disease management, improve severity prediction, and identify potential therapeutic targets to prevent severe outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ Group 1: Dengue without warning signs Patients presenting with the following symptoms confirmed positive for dengue infection by lab diagnosis by anti-dengue IgM or NS1 ELISA will be recruited for the study under this cohort.

⁃ Symptoms will be fever along with at least two of the following -

• Myalgia, arthralgia

• Nausea and/or vomiting

• Rashes

• Leukopenia Group 2: DENV with warning signs This cohort will include patients with the above symptoms and any of the following clinical signs.

• Abdominal pain with tenderness

• Persistent vomiting

• Fluid accumulation

• Mucosal bleeding

• Restlessness, lethargy

• Liver enlargement \>2cm

• Laboratory findings: An increase in hematocrit levels and a rapid decrease in platelet count Group 3: Severe dengue

• Severe plasma leakage leads to hypovolemic shock (dengue shock syndrome) and fluid accumulation with respiratory distress.

• Severe bleeding, such as epistaxis, internal bleeding, etc., is evaluated by a clinician.

• Severe organ involvement with any of the following symptoms

• Liver AST or ALT ≥ 1000

• CNS: impaired consciousness

• Heart and other organs failure

Locations
Other Locations
Guatemala
Bio Box Guatemala Ong de Investigación, Servicios Y de Medio Ambiente
RECRUITING
Guatemala City
India
Manipal Academy of Higher Education (MAHE)
RECRUITING
Mangalore
Contact Information
Primary
Ujjwal Neogi, PhD
ujjwal.neogi@ki.se
+46 8524 83680
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 1400
Treatments
Dengue without warning signs (DwoWS)
Laboratory confirmed Dengue without plasma leakage
Dengue with warning signs (DWS)
Laboratory confirmed Dengue without plasma leakage plus abdominal pain, persistent vomiting, fluid accumulation, mucosal bleeding, lethargy, liver enlargement, increasing haematocrit with decreasing platelets
Severe Dengue (SD)
Dengue with severe plasma leakage, severe bleeding, or organ failure
Healthy Control
Healthy participants who have tested negative for dengue infection
Related Therapeutic Areas
Sponsors
Collaborators: DEVKI DEVI FOUNDATION SOCIETY, India, BIO BOX GUATEMALA ONG DE INVESTIGACIÓN, SERVICIOS Y DE MEDIO AMBIENTE, Artemis Medicare Services Ltd., India, MANIPAL ACADEMY OF HIGHER EDUCATION, India
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov