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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | 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 | Children with definitive dengue infection enrolled for gene expression analysis. |
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| 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 |
| 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. |
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Inclusion Criteria Part A:
Inclusion Criteria Part B:
Exclusion Criteria for both parts:
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Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Adderson, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States | ||
| Hospital Nacional de Ninos Benjamin Bloom |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| 1 Year |
| San Salvador |
| El Salvador |
| El Salvador |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |