Clinical trial NCT00946218: Diagnosis and Characterization of Dengue Fever in Children
Official title: Diagnosis and Characterization of Dengue Fever in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Fever
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 258
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays.
timeFrame: 1 Year
measure: To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: San Salvador
country: El Salvador
facility: Hospital Nacional de Ninos Benjamin Bloom
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Elisabeth Adderson, MD
role: PRINCIPAL_INVESTIGATOR
References: