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.
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)
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.
Any non-steroidal anti-inflammatory, antiplatelet or anticoagulant medication received in preceding 7 days.
Patients presenting to Khánh Hòa Hospital of Tropical Diseases, Nha Trang, Vietnam.
Cohort
Prospective
Not listed
Degree of vascular leak
Presence and severity of vascular leak (none, moderate, severe) per Tomashek et al. 2018 consensus definitions - composite of change of haematocrit from baseline, presence of ascites/pleural effusion by point of care ultrasound and presence of respiratory/cardiovascular compromise.
Multi-state model evaluation - precision
Confidence in model parameters: 95% confidence interval width around 3- and 5-day probabilities of all state transition pairs (probability with 95% confidence interval)
Multi-state model evaluation: model fit
Goodness of fit of model compared to observed data, as assessed by Akaike information criteria (AIC) values, Bayesian information criteria (BIC) values and Likelihood-ratio test (p-value)
Viral dynamics
Dengue viral load by reverse-transcriptase polymerase chain reaction (copies per microlitre)
Degree of thrombocytopenia
Presence and severirty of thrombocytopenia (none, moderate, severe) per Tomashek et al. 2018 consensus definitions - measured by platelet count (10\^9/L)
Click on the lead sponsor to view all of their trials.
Liverpool School of Tropical Medicine
Lead sponsor
Nagasaki University
Collaborator
Pasteur Institute, Nha Trang
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
