NCT06751836 Innovative Multidisciplinary Strategies for Combating Severe Dengue
| NCT ID | NCT06751836 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | DENV Without Warning Signs |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,400 participants in total. It began in 2025-01-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06751836 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying DENV Without Warning Signs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06751836 currently recruiting?
Yes, NCT06751836 is actively recruiting participants. Contact the research team at ujjwal.neogi@ki.se for enrollment information.
Where is the NCT06751836 trial being conducted?
This trial is being conducted at Guatemala City, Guatemala, Mangalore, India.
Who is sponsoring the NCT06751836 clinical trial?
NCT06751836 is sponsored by Karolinska Institutet. The trial plans to enroll 1,400 participants.