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Diagnosis and Characterization of Dengue Fever in Children

NCT ID: NCT00946218

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Dengue Fever

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Part B

Children with definitive dengue infection enrolled for gene expression analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* Obvious alternative explanation for the actual illness
* Cellulitis/Abscess
* Osteomyelitis
* Varicella
* Urinary Tract Infection
* Known immunocompromising condition
Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Adderson, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Hospital Nacional de Ninos Benjamin Bloom

San Salvador, El Salvador, El Salvador

Site Status

Countries

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United States El Salvador

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

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DENGEN

Identifier Type: -

Identifier Source: org_study_id