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Clinical Trials in India / NCT06751836
Recruiting Observational

Innovative Multidisciplinary Strategies for Combating Severe Dengue

NCT06751836 · tracked via the Priya Life Science India tracker
Sponsor
Karolinska Institutet
Phase
Observational
Started
2025-01-03
Last updated
2025-02-10

Condition(s) studied

DENV Without Warning SignsDENV with Warning SignsSevere DengueHealthy Controls Group - Age and Sex-matched

Investigational drug(s) / intervention(s)

Infection and no infection

Infection and no infection: No intervention apart from the dengue infection

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: 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 Exclusion Criteria: \-

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Bio Box Guatemala Ong de Investigación, Servicios Y de Medio Ambiente Guatemala City Guatemala Recruiting
Manipal Academy of Higher Education (MAHE) Mangalore Karnataka Recruiting

More Karolinska Institutet trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06751836 on ClinicalTrials.gov ↗ ← All trials in India