Dengue FeverNCT00946218
Diagnosis and Characterization of Dengue Fever in Children
An observational study of Dengue Fever, run by St. Jude Children's Research Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Dengue Fever
- How many people
- 258 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.
Who may be able to join
- 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
Who cannot join
- Obvious alternative explanation for the actual illness
- Cellulitis/Abscess
- Osteomyelitis
- Varicella
- Urinary Tract Infection
- Known immunocompromising condition
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
El Salvador1 site
Hospital Nacional de Ninos Benjamin Bloom
San Salvador, El Salvador
About this study
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.
Read the 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.
- Conditions
- Dengue Fever
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Year
To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Adderson, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946218
- Sponsor's protocol ID
- DENGEN
- Status last verified
- Oct 2011
- First submitted
- 22 Jul 2009
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Characterization of Dengue Fever in Children
- ClinicalTrials.gov ID
- NCT00946218
- Acronym / sponsor ID
- DENGEN
- Conditions
- Dengue Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Obvious alternative explanation for the actual illness
- Cellulitis/Abscess
- Osteomyelitis
- Varicella
- Urinary Tract Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data.
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Adderson, MD principal investigator
St. Jude Children's Research Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever, run by St. Jude Children's Research Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.