Dengue FeverNCT01421732
Laboratory Diagnosis and Prognosis of Severe Dengue
An observational study of Dengue Fever, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial summary
A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho Chi Minh City and Tien Giang province, Viet Nam. Different blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to… Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Dengue Fever
- How many people
- 8,100 participants
- Where
- 1 siteVietnam
- Study dates
- Oct 2010to Dec 2014
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient presenting to outpatient department of participating hospitals with symptoms of dengue fever
Who may be able to join
- Clinical suspicion of dengue
- Axillary temperature >=37.5C
- Less than 72hrs of fever
- Resident in Ho Chi Minh City
- 1-15 yrs of age
- Accompanying family member or guardian has a mobile phone
- Written informed consent
Who cannot join
- Any patient who the attending physician believes is unlikely to be able to attend follow-up
- Any patient in who the attending physician believes another diagnosis is more likely.
Trial locations and contacts
1 site in 1 country.
About this study
A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho Chi Minh City and Tien Giang province, Viet Nam.
Different blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to severe disease.
Read the detailed description
In a prospective study in the outpatients department of three large hospitals in Ho Chi Minh City, Viet Nam, we will determine the early diagnostic sensitivity, specificity, positive and negative predictive values of two NS1 diagnostic tests in severe dengue cases.
The study is intended to develop a prognostic algorithm for the early identification of severe dengue cases.
Routine demographic, haematological and biochemical laboratory markers will be utilized to derive a prognostic algorithm that is clinically-useful for guiding patient triage and interventions.
We hope to discover and evaluate new early biomarkers of severe dengue and will evaluate candidate host response molecules and virological markers for their prognostic value.
We further plan to understand the phylogeography of DENV in the super-urban setting of HCMC.
We will use genome scale sequencing of DENV together with geospatial information on the residential addresses of patients to better understand transmission dynamics in space and time in a high transmission super-urban district of HCMC and thereby identify opportunities for public health interventions.
- Conditions
- Dengue Fever
- Keywords
- Dengue fever, severe dengue fever, NS1 detection assay, Prognosis, Diagnosis
- Medical subject headings
- Dengue, Disease
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 |
|---|---|---|
| Suspected dengue fever | Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Percentage of detection assays which correctly predict laboratory-confirmed severe dengue.
Measured: Within the first 72 hours of fever onset
Specificity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Percentage of detection assays which correctly predict different dengue serotypes.
Measured: Within the first 72 hours of fever onset
Positive predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Percentage of detection assays which correctly predict dengue infection.
Measured: Within the first 72 hours of fever onset
Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Percentage of detection assays which correctly predict no dengue infection.
Measured: Within the first 72 hours of fever onset
Secondary outcomes (4)
Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.
Percentage of detection assays which correctly predict requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
Measured: Estimated within 6 days of presentation
Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.
Percentage of detection assays which correctly predict no requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
Measured: Estimated within 6 days of presentation
Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.
Percentage of detection assays which correctly predict the requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
Measured: Estimated within 6 days of presentation
Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy.
Percentage of detection assays which correctly predict the dengue serotype and it's correlation to a requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
Measured: Estimated within 6 days of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- Prospective
- Enrolment
- 8,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Number 2 Children's Hospital, Ho Chi Minh City, Tien Giang Provincial Hospital, Tien Giang, Viet Nam, Red Cross Clinic Of District 8
- Responsible party
- Sponsor
- Investigators
- Cameron Simmons, PhD, Principal investigator, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421732
- Sponsor's protocol ID
- 13DX
- Status last verified
- Sep 2016
- First submitted
- 22 Aug 2011
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Diagnosis and Prognosis of Severe Dengue
- ClinicalTrials.gov ID
- NCT01421732
- Acronym / sponsor ID
- 13DX
- Conditions
- Dengue Fever
- Keywords
- Dengue fever, severe dengue fever, NS1 detection assay, Prognosis, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,100 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Number 2 Children's Hospital, Ho Chi Minh City, Tien Giang Provincial Hospital, Tien Giang, Viet Nam, Red Cross Clinic Of District 8
- Study start
- Oct 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Aug 2011 (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.
A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho Chi Minh City and Tien Giang province, Viet Nam.
Different blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to severe disease.
Detailed description
In a prospective study in the outpatients department of three large hospitals in Ho Chi Minh City, Viet Nam, we will determine the early diagnostic sensitivity, specificity, positive and negative predictive values of two NS1 diagnostic tests in severe dengue cases.
The study is intended to develop a prognostic algorithm for the early identification of severe dengue cases.
Routine demographic, haematological and biochemical laboratory markers will be utilized to derive a prognostic algorithm that is clinically-useful for guiding patient triage and interventions.
We hope to discover and evaluate new early biomarkers of severe dengue and will evaluate candidate host response molecules and virological markers for their prognostic value.
We further plan to understand the phylogeography of DENV in the super-urban setting of HCMC.
We will use genome scale sequencing of DENV together with geospatial information on the residential addresses of patients to better understand transmission dynamics in space and time in a high transmission super-urban district of HCMC and thereby identify opportunities for public health interventions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected dengue fever | – | –Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient presenting to outpatient department of participating hospitals with symptoms of dengue fever
Key inclusion criteria (7 listed)
- Clinical suspicion of dengue
- Axillary temperature >=37.5C
- Less than 72hrs of fever
- Resident in Ho Chi Minh City
- 1-15 yrs of age
Key exclusion criteria (2 listed)
- Any patient who the attending physician believes is unlikely to be able to attend follow-up
- Any patient in who the attending physician believes another diagnosis is more likely.
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
Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Time frame: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict laboratory-confirmed severe dengue.
Specificity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Time frame: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict different dengue serotypes.
Positive predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Time frame: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict dengue infection.
Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
Time frame: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict no dengue infection.
4 secondary outcomes
Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.
Time frame: Estimated within 6 days of presentation
Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.
Time frame: Estimated within 6 days of presentation
Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.
Time frame: Estimated within 6 days of presentation
Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy.
Time frame: Estimated within 6 days of presentation
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 30 Sep 2016.
- Oxford University Clinical Research UnitLink provided by the sponsor.
- Study details and Informed Consent FormLink 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.
Cameron Simmons, PhD principal investigator
Oxford University Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
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 7 inclusion and 2 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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?
Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue. (time frame: Within the first 72 hours of fever onset). The study lists 4 primary outcomes in all. 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 30 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.