NCT01421732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

4.2 years

First QC Date

August 22, 2011

Last Update Submit

September 29, 2016

Conditions

Dengue Fever

Keywords

Dengue feversevere dengue feverNS1 detection assayPrognosisDiagnosis

Outcome Measures

Primary Outcomes (4)

  • Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.

    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.

    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.

    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.

    Percentage of detection assays which correctly predict no dengue infection.

    Within the first 72 hours of fever onset

Secondary Outcomes (4)

  • Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.

    Estimated within 6 days of presentation

  • Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.

    Estimated within 6 days of presentation

  • Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.

    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.

    Estimated within 6 days of presentation

Study Arms (1)

Suspected dengue fever

Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Clinical suspicion of dengue
  • Axillary temperature \>=37.5C
  • Less than 72hrs of fever
  • Resident in Ho Chi Minh City
  • yrs of age
  • Accompanying family member or guardian has a mobile phone
  • Written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Tropical Diseases

Ho Chi Minh City, Ho Chi Minh, Vietnam

Location

Related Links

MeSH Terms

Conditions

DengueDisease

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cameron Simmons, PhD

    Oxford University Clinical Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 23, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

VN(1)