Diagnosis and Characterization of Dengue Fever in Children
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Diagnosis and Characterization of Dengue Fever in Children|
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Children with presumptive dengue infection enrolled for empiric cost modeling with retrospective clinical estimation and comparison of test performance to the standard of care.
Children with definitive dengue infection enrolled for gene expression analysis.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946218
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Hospital Nacional de Ninos Benjamin Bloom|
|San Salvador, El Salvador|
|Principal Investigator:||Elisabeth Adderson, MD||St. Jude Children's Research Hospital|