Diagnosis and Characterization of Dengue Fever in Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00946218

Enrollment

258

Registered

2009-07-24

Start date

2009-07-31

Completion date

2009-12-31

Last updated

2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue Fever

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 11 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

El Salvador, United States

Outcome results