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Trial record 9 of 97 for:    "Dengue Hemorrhagic Fever"

Diagnosis and Characterization of Dengue Fever in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946218
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : October 5, 2011
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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
Dengue Fever

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.

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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 : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946218

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

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital Identifier: NCT00946218     History of Changes
Other Study ID Numbers: DENGEN
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

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