Laboratory Diagnosis and Prognosis of Severe Dengue

NCT ID: NCT01421732

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-12-31

Brief Summary

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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 Description

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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.

Conditions

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Dengue Fever

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected dengue fever

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

Number 2 Children's Hospital, Ho Chi Minh City

OTHER

Sponsor Role collaborator

Tien Giang Provincial Hospital, Tien Giang, Viet Nam

UNKNOWN

Sponsor Role collaborator

Red Cross Clinic Of District 8

OTHER

Sponsor Role collaborator

Oxford University Clinical Research Unit, Vietnam

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cameron Simmons, PhD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Clinical Research Unit

Locations

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Hospital for Tropical Diseases

Ho Chi Minh City, Ho Chi Minh, Vietnam

Site Status

Countries

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Vietnam

Related Links

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http://www.oucru.org

Oxford University Clinical Research Unit

Other Identifiers

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13DX

Identifier Type: -

Identifier Source: org_study_id

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