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Diagnosis and Characterization of Dengue Fever in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00946218
First received: July 22, 2009
Last updated: October 3, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Dengue Fever

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Diagnosis and Characterization of Dengue Fever in Children

Resource links provided by NLM:

MedlinePlus related topics: Dengue Fever
U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946218

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
El Salvador
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
  More Information

Additional Information:
St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00946218     History of Changes
Other Study ID Numbers: DENGEN
Study First Received: July 22, 2009
Last Updated: October 3, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dengue
Dengue Hemorrhagic Fever
Fever
Arbovirus Infections
Virus Diseases
Flavivirus Infections
 Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013