Laboratory Diagnosis and Prognosis of Severe Dengue

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01421732

Enrollment

8100

Registered

2011-08-23

Start date

2010-10-31

Completion date

2014-12-31

Last updated

2016-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue Fever

Keywords

Dengue fever, severe dengue fever, NS1 detection assay, Prognosis, Diagnosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 15 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.	Within the first 72 hours of fever onset	Percentage of detection assays which correctly predict no dengue infection.
Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.	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.	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.	Within the first 72 hours of fever onset	Percentage of detection assays which correctly predict dengue infection.

Secondary

Measure	Time frame	Description
Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.	Estimated within 6 days of presentation	Percentage of detection assays which correctly predict requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.	Estimated within 6 days of presentation	Percentage of detection assays which correctly predict no requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.	Estimated within 6 days of presentation	Percentage of detection assays which correctly predict the requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy.	Estimated within 6 days of presentation	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).

Countries

Vietnam

Outcome results