Laboratory Diagnosis and Prognosis of Severe Dengue

Dengue Fever Clinical Trial

Official title:

Laboratory Diagnosis and Prognosis of Severe Dengue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421732
• Other study ID #: 13DX
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: September 29, 2016
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Department of Health, Ho Chi Minh City
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Severe Dengue

Locations

Country	Name	City	State
Vietnam	Hospital for Tropical Diseases	Ho chi Minh

Sponsors (6)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Children's Hospital Number 2, Ho Chi Minh City, Vietnam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Red Cross Clinic Of District 8, Tien Giang Provincial Hospital, Tien Giang, Viet Nam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.	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	No
Secondary	Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.	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	No
Secondary	Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.	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	No
Secondary	Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy.	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	No

External Links

•   Oxford University Clinical Research Unit
•   Study details and Informed Consent Form