Clinical trial NCT01421732: Laboratory Diagnosis and Prognosis of Severe Dengue
Official title: Laboratory Diagnosis and Prognosis of Severe Dengue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Fever
Keywords: Dengue fever
severe dengue fever
NS1 detection assay
Prognosis
Diagnosis
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
name: Children's Hospital Number 1, Ho Chi Minh City, Vietnam
name: Number 2 Children's Hospital, Ho Chi Minh City
name: Tien Giang Provincial Hospital, Tien Giang, Viet Nam
name: Red Cross Clinic Of District 8
First posted: 2011-08-23
Enrollment: 8100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient presenting to outpatient department of participating hospitals with symptoms of dengue fever

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
timeFrame: Within the first 72 hours of fever onset
measure: Specificity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
timeFrame: Within the first 72 hours of fever onset
measure: Positive predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
timeFrame: Within the first 72 hours of fever onset
measure: Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
timeFrame: Within the first 72 hours of fever onset
Secondary outcomes:
measure: Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.
timeFrame: Estimated within 6 days of presentation
measure: Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.
timeFrame: Estimated within 6 days of presentation
measure: Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.
timeFrame: Estimated within 6 days of presentation
measure: Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy.
timeFrame: Estimated within 6 days of presentation
Other outcomes:
Locations:
city: Ho chi Minh
country: Vietnam
facility: Hospital for Tropical Diseases
Study officials:
affiliation: Oxford University Clinical Research Unit
name: Cameron Simmons, PhD
role: PRINCIPAL_INVESTIGATOR
References: