Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06751836

Innovative Multidisciplinary Strategies for Combating Severe Dengue

Led by Karolinska Institutet · Updated on 2025-02-10

1400

Participants Needed

2

Research Sites

251 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

B

BIO BOX GUATEMALA ONG DE INVESTIGACIÓN, SERVICIOS Y DE MEDIO AMBIENTE

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Innovative Multidisciplinary Strategies for Combating Severe Dengue

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Patients with dengue infection confirmed by anti-dengue IgM or NS1 ELISA
  • For dengue without warning signs: fever plus at least two of the following symptoms: muscle or joint pain, nausea or vomiting, rashes, or low white blood cell count
  • For dengue with warning signs: presence of dengue symptoms plus one or more of the following: abdominal pain with tenderness, persistent vomiting, fluid accumulation, mucosal bleeding, restlessness or lethargy, liver enlargement greater than 2 cm, increased hematocrit and rapid platelet count decrease
  • For severe dengue: severe plasma leakage causing shock, severe bleeding evaluated by clinician, or severe organ involvement including liver enzymes AST or ALT ≥ 1000, impaired consciousness, or heart/other organ failure
  • Healthy controls matched by age and sex who tested negative for dengue infection in the past three months
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Bio Box Guatemala Ong de Investigación, Servicios Y de Medio Ambiente

Guatemala City, Guatemala

Actively Recruiting

2

Manipal Academy of Higher Education (MAHE)

Mangalore, Karnataka, India, 576104

Actively Recruiting

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Research Team

U

Ujjwal Neogi, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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