Laboratory Diagnosis and Prognosis of Severe Dengue

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Oxford University Clinical Research Unit, Vietnam
Sponsor:
Collaborators:
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Children's Hospital No.1, Ho Chi Minh City, Viet Nam
Children's Hospital No.2, Ho Chi Minh City, Viet Nam
Tien Giang Provincial Hospital, Tien Giang, Viet Nam
District 8 Hospital, Ho Chi Minh City, Viet Nam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01421732
First received: August 22, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition
Dengue Fever

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Laboratory Diagnosis and Prognosis of Severe Dengue

Resource links provided by NLM:


Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue. [ Time Frame: Within the first 72 hours of fever onset ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of detection assays which correctly predict no dengue infection.


Secondary Outcome Measures:
  • Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy. [ Time Frame: Estimated within 6 days of presentation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Enrollment: 13500
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Suspected dengue fever
Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever

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.

  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421732

Contacts
Contact: Cameron Simmons, PhD +84389241983 lmerson@oucru.org

Locations
Vietnam
Hospital for Tropical Diseases Recruiting
Ho chi Minh, Vietnam
Contact: Nguyen Van Vinh Chau, MD    84 8 39238904    chaunvv@oucru.org   
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Children's Hospital No.1, Ho Chi Minh City, Viet Nam
Children's Hospital No.2, Ho Chi Minh City, Viet Nam
Tien Giang Provincial Hospital, Tien Giang, Viet Nam
District 8 Hospital, Ho Chi Minh City, Viet Nam
Investigators
Principal Investigator: Cameron Simmons, PhD Oxford University Clinical Research Unit
  More Information

Additional Information:
No publications provided

Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01421732     History of Changes
Other Study ID Numbers: 13DX
Study First Received: August 22, 2011
Last Updated: June 25, 2014
Health Authority: Vietnam: Department of Health, Ho Chi Minh City

Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Dengue fever
severe dengue fever
NS1 detection assay
Prognosis
Diagnosis

Additional relevant MeSH terms:
Dengue
Severe Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on October 01, 2014