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Completed

NCT Number: NCT01421732

Laboratory Diagnosis and Prognosis of Severe Dengue

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.

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Key information

Conditions

Dengue Fever Arbovirus Infections Dengue Disease Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Tropical Diseases

Ho Chi Minh City, Ho Chi Minh, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

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
  • Red Cross Clinic Of District 8
  • Tien Giang Provincial Hospital, Tien Giang, Viet Nam

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2011
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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