Clinical Trial: Laboratory Diagnosis and Prognosis of Severe Dengue

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Laboratory Diagnosis and Prognosis of Severe Dengue

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 Summary:

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.

Sponsor: Oxford University Clinical Research Unit, Vietnam

Current 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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).

Original Secondary Outcome: Same as current

Information By: Oxford University Clinical Research Unit, Vietnam

Dates:
Date Received: August 22, 2011
Date Started: October 2010
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016