Clinical Trial: Diagnosis and Characterization of Dengue Fever in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Diagnosis and Characterization of Dengue Fever in Children

Brief Summary: 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 Summary: 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.
Sponsor: St. Jude Children's Research Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]
  • To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data. [ Time Frame: 1 Year ]


Original Secondary Outcome:

Information By: St. Jude Children's Research Hospital

Dates:
Date Received: July 22, 2009
Date Started: July 2009
Date Completion:
Last Updated: October 3, 2011
Last Verified: October 2011