Diagnosis and Characterization of Dengue Fever in Children

Completed

• Conditions: Dengue Fever

• Registration Number: NCT00946218
• Lead Sponsor: St. Jude Children's Research Hospital

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 Description

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-03
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Hospital Nacional de Ninos Benjamin Bloom; 🇸🇻 San Salvador, El Salvador