Diagnosis and Characterization of Dengue Fever in Children

Study Overview
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Brief Summary
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Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and mortality among children in tropical regions, especially in resource limited countries. The objective of this protocol is to compare the sensitivity and specificity of clinical gestalt and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes in distinct dengue fever disease phenotypes module-based RNA microarray technology.

Detailed Description
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This is a biology protocol with no treatment regimen associated. Blood collection will be drawn from subjects in El Salvador to be tested in an effort to improve detection and test sensitivity and specificity of a dengue NS1 Ag ELISA, dengue NS1 Ag STRIP, and clinical suspicion for the detection of dengue virus infection in children in San Salvador, El Salvador compared to the gold standard, PCR. This protocol will also seek to identify and compare gene transcription patterns characteristics of each dengue virus disease phenotype in children.

Official Title
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Diagnosis and Characterization of Dengue Fever in Children

Conditions
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Dengue Fever

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Part A: Age: Greater than or equal to 6 months and less than 13 years One of the following; History of fever OR a history of spontaneous or provoked bleeding Inclusion Criteria Part B: Gender: Female Age: greater than or equal to 36 months Tanner stage less than 2 One of the following criteria: Classical Dengue Fever, Dengue Hemorrhagic Fever or Dengue Shock Syndrome Exclusion Criteria for both parts: Obvious alternative explanation for the actual illness Cellulitis/Abscess Osteomyelitis Varicella Urinary Tract Infection Known immunocompromising condition

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 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 |
| --- | --- |
| Part A<br>Children with presumptive dengue infection enrolled for empiric cost modeling with retrospective clinical estimation and comparison of test performance to the standard of care. | |
| Part B<br>Children with definitive dengue infection enrolled for gene expression analysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the sensitivity of dengue NS1 (influenze protein) Ag Enzyme-linked Immunosorbent Assay and dengue NS1 Ag STRIP and WHO clinical diagnostic criteria when applied to children in El Salvador. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays. |  | 1 Year | 
| To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data. |  | 1 Year |