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Not Yet Recruiting NCT07799168

Investigating and Modelling the Natural History of Dengue in Hospitalised Patients to Improve Future Research

Conditions: Dengue

Sex: All
Ages: 16 Years – N/A
Healthy volunteers: Yes
Enrollment: 235
Sponsor: Liverpool School of Tropical Medicine

Location: Nagasaki University Vietnam Research Station, Nha Trang Nha Trang

Summary

The goal of this observational study is to investigate the natural history of dengue in hospitalised patients in Vietnam, to better understand the disease process, and utilise the data to improve future clinical trials. The main questions it aims to answer are: In participants hospitalised with dengue in Vietnam: 1. How does dengue illness change over time, particularly the development and recovery of vascular leak (where blood vessels leak)? 2. Can a new statistical approaches describe dengue illness accurately and be suitable for use in future clinical trials? 3. Which blood biomarkers are associated with worsening or improving dengue illness, and what do they tell us about how severe dengue develops? Could these blood biomarkers act as reliable indicators of disease severity and recovery, making them useful outcome measures in future dengue treatment trials? 4. How accurately do simplified diagnostic tests identify dengue compared with laboratory reference methods, and are they suitable for use in research and clinical settings in low- and middle-income countries? Participants will be observed without any intervention throughout their hospitalisation. Participants will be be asked to provide informed consent for: * Recording of their routine clinical data * Regular blood tests * Regular ultrasound scans * A follow up appointment.

Eligibility Criteria

Inclusion Criteria (hospitalised cohort): * Meet the 2009 WHO criteria for dengue with warning signs or severe dengue AND * Are being admitted as an inpatient AND * Have documented standard-of-care laboratory confirmation of dengue (defined as either positive by molecular assay (e.g. reverse transcription polymerase chain reaction) OR positive by antigen testing (non-structural protein-1) OR positive Immunoglobulin M (IgM) combined with clinical diagnosis of dengue by attending physician. AND * Were born in Vietnam (only for platelet phenomics substudy) Inclusion Criteria (diagnostic control cohort): * Have a documented fever at assessment AND * Have a documented negative standard-of-care dengue test, with no clinical diagnosis of dengue AND * Were born in Vietnam (only for platelet phenomics substudy) Inclusion Criteria (platelet control cohort): * Vietnamese-born adults ≥16 years of age with no history of febrile illness in the preceding 14 days. Exclusion Criteria: * Receiving an experimental dengue treatment during their illness. * Inability to provide written, informed consent AND no legal guardian able to provide written, informed consent in the event of incapacity. * Clinician-determined unsuitability for recruitment. Exclusion Criteria (platelet substudy only): * Any non-steroidal anti-inflammatory, antiplatelet or anticoagulant medication received in preceding 7 days.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07799168). StuddyBuddy aggregates publicly available trial information.