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OpenTrials
Completed

NCT Number: NCT00946218

Diagnosis and Characterization of Dengue Fever in Children

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.

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Key information

Conditions

Dengue Fever Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Nacional de Ninos Benjamin Bloom, San Salvador, El Salvador

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 24, 2009
Registry last updated
Oct 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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