Diagnosis and Characterization of Dengue Fever in Children
1 other identifier
observational
258
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 5, 2011
October 1, 2011
5 months
July 22, 2009
October 3, 2011
Conditions
Outcome Measures
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.
1 year
Secondary Outcomes (2)
To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays.
1 Year
To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data.
1 Year
Study Arms (2)
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.
Eligibility Criteria
Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.
You may qualify if:
- 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
You may not qualify if:
- Obvious alternative explanation for the actual illness
- Cellulitis/Abscess
- Osteomyelitis
- Varicella
- Urinary Tract Infection
- Known immunocompromising condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Hospital Nacional de Ninos Benjamin Bloom
San Salvador, El Salvador, El Salvador
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisabeth Adderson, MD
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2009
First Posted
July 24, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
October 5, 2011
Record last verified: 2011-10