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Diagnosis and Characterization of Dengue Fever in Children

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00946218
Collaborator
(none)
258
Enrollment
2
Locations
5
Duration (Months)
129
Patients Per Site
25.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    258 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Diagnosis and Characterization of Dengue Fever in Children
    Study Start Date :
    Jul 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Dec 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Part A

    Children with presumptive dengue infection enrolled for empiric cost modeling with retrospective clinical estimation and comparison of test performance to the standard of care.
    Part B

    Children with definitive dengue infection enrolled for gene expression analysis.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays. [1 Year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    2 Hospital Nacional de Ninos Benjamin Bloom San Salvador El Salvador

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital

    Investigators

    • Principal Investigator: Elisabeth Adderson, MD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT00946218
    Other Study ID Numbers:
    • DENGEN
    First Posted:
    Jul 24, 2009
    Last Update Posted:
    Oct 5, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:
    Dengue
    Fever

    Study Results

    No Results Posted as of Oct 5, 2011