Diagnosis and Characterization of Dengue Fever in Children

Dengue Fever Clinical Trial

Official title:

Diagnosis and Characterization of Dengue Fever in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946218
• Other study ID #: DENGEN
• Status: Completed
• Phase: N/A
• First received: July 22, 2009
• Last updated: October 3, 2011
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: October 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 11 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Fever

Locations

Country	Name	City	State
El Salvador	Hospital Nacional de Ninos Benjamin Bloom	San Salvador
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Countries where clinical trial is conducted

United States,  El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays.		1 Year	No
Secondary	To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data.		1 Year	No

External Links

•   St. Jude Children's Research Hospital