Laboratory Diagnosis and Prognosis of Severe Dengue

Study Overview
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Brief Summary
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A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho Chi Minh City and Tien Giang province, Viet Nam. Different blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to severe disease.

Detailed Description
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In a prospective study in the outpatients department of three large hospitals in Ho Chi Minh City, Viet Nam, we will determine the early diagnostic sensitivity, specificity, positive and negative predictive values of two NS1 diagnostic tests in severe dengue cases. The study is intended to develop a prognostic algorithm for the early identification of severe dengue cases. Routine demographic, haematological and biochemical laboratory markers will be utilized to derive a prognostic algorithm that is clinically-useful for guiding patient triage and interventions. We hope to discover and evaluate new early biomarkers of severe dengue and will evaluate candidate host response molecules and virological markers for their prognostic value. We further plan to understand the phylogeography of DENV in the super-urban setting of HCMC. We will use genome scale sequencing of DENV together with geospatial information on the residential addresses of patients to better understand transmission dynamics in space and time in a high transmission super-urban district of HCMC and thereby identify opportunities for public health interventions.

Official Title
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Laboratory Diagnosis and Prognosis of Severe Dengue

Conditions
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Dengue Fever

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical suspicion of dengue Axillary temperature >=37.5C Less than 72hrs of fever Resident in Ho Chi Minh City 1-15 yrs of age Accompanying family member or guardian has a mobile phone Written informed consent Exclusion Criteria: Any patient who the attending physician believes is unlikely to be able to attend follow-up Any patient in who the attending physician believes another diagnosis is more likely.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected dengue fever<br>Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue. | Percentage of detection assays which correctly predict laboratory-confirmed severe dengue. | Within the first 72 hours of fever onset | 
| Specificity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue. | Percentage of detection assays which correctly predict different dengue serotypes. | Within the first 72 hours of fever onset | 
| Positive predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue. | Percentage of detection assays which correctly predict dengue infection. | Within the first 72 hours of fever onset | 
| Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue. | Percentage of detection assays which correctly predict no dengue infection. | Within the first 72 hours of fever onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy. | Percentage of detection assays which correctly predict requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability). | Estimated within 6 days of presentation | 
| Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy. | Percentage of detection assays which correctly predict no requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability). | Estimated within 6 days of presentation | 
| Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy. | Percentage of detection assays which correctly predict the requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability). | Estimated within 6 days of presentation | 
| Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy. | Percentage of detection assays which correctly predict the dengue serotype and it's correlation to a requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability). | Estimated within 6 days of presentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dengue fever, severe dengue fever, NS1 detection assay, Prognosis, Diagnosis