Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Innovative strategies to understand and combat severe dengue

Official title: Advancing Pandemic Preparedness: Innovative Multidisciplinary Strategies for COMBATing Severe Dengue

Run by Karolinska Institutet · NCT06751836 · Data updated 2026-11-12

This study is trying to find out what makes dengue infections more severe by looking at blood samples from patients in areas where dengue is common, to help improve treatment and prevention.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1400 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations2 sites (Guatemala City and 1 other locations)
StatusRecruiting
StartedJanuary 3, 2025
Main results expectedDecember 31, 2026
Study endsOctober 31, 2029
Registry record updatedFebruary 10, 2025
Trial IDNCT06751836 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with dengue, either with or without warning signs, as well as healthy controls matched by age and sex.

Probably not a fit

Patients with non-dengue viral infections or those who do not meet the inclusion criteria for dengue infection may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify biomarkers and host factors associated with the severity of dengue infections in patients from dengue-endemic regions. By employing multi-omics approaches, the study will analyze blood samples from individuals with dengue to uncover immune responses, disease pathogenesis, and cellular interactions. It will also investigate the impact of primary and secondary infections, virus serotypes, and immunological factors on disease progression. The findings are expected to enhance disease management, improve severity prediction, and identify potential therapeutic targets to prevent severe outcomes.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction and management of severe dengue, potentially reducing morbidity and mortality associated with the disease.

How similar studies have gone: While many studies have focused on therapeutic compounds and vaccines for dengue, this multi-omics approach to understanding disease severity is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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:

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Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.