Laboratory Diagnosis and Prognosis of Severe Dengue

Oxford University Clinical Research Unit, Vietnam

Status: Completed

Conditions: Dengue Fever

Study type: Observational

Funder types: Other

Identifiers

NCT01421732

13DX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,100 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

8,100 participants in 1 patient group

Suspected dengue fever

Description:

Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever