Innovative strategies to understand and combat severe dengue
Advancing Pandemic Preparedness: Innovative Multidisciplinary Strategies for COMBATing Severe Dengue
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 type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Guatemala City and 1 other locations) |
| Trial ID | NCT06751836 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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: \-
Where this trial is running
Guatemala City and 1 other locations
- 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
- Study coordinator: Ujjwal Neogi, PhD
- Email: ujjwal.neogi@ki.se
- Phone: +46 8524 83680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.