Laboratory Diagnosis and Prognosis of Severe Dengue

September 29, 2016 updated by: Oxford University Clinical Research Unit, Vietnam

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

8100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho chi Minh, Vietnam
        • Hospital for Tropical Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient presenting to outpatient department of participating hospitals with symptoms of dengue fever

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Suspected dengue fever
Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 72 hours of fever onset
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.
Within the first 72 hours of fever onset
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.
Within the first 72 hours of fever onset
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.
Within the first 72 hours of fever onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Percentage of detection assays which correctly predict no requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
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
Percentage of detection assays which correctly predict the requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).
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
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).
Estimated within 6 days of presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

Children's Hospital Number 1, Ho Chi Minh City, Vietnam
Hospital for Tropical Diseases, 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

Investigators

  • Principal Investigator: Cameron Simmons, PhD, Oxford University Clinical Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (ESTIMATE)

August 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13DX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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