The Use of Biomarkers in Predicting Dengue Outcome

October 24, 2016 updated by: Gary Kim Kuan Low, Universiti Tunku Abdul Rahman

The burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in differentiating severe dengue from non-severe dengue cases. The analysis between severe dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at the margin of the pre-determined p-value of less than 0.05.

Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and liver function test (alanine aminotransferase and aspartate).

Study Overview

Status

Unknown

Conditions

Detailed Description

The burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in differentiating severe dengue from non-severe dengue cases. The analysis between severe dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at the margin of the pre-determined p-value of less than 0.05.

Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and liver function test (alanine aminotransferase and aspartate).

This is a prospective cohort study in which the patient will be followed up from the day of presentation to the attending practitioner until the patient is discharged. The blood samples will be obtained daily during the follow-up. The demography and clinical final diagnosis will be obtained from the medical record of the patient.

This study will aid triaging of dengue cases thereby reducing the need of unnecessary admission and better focused management to those might develop complication of dengue infection. This in turn reduces the workload and cost of the treating the dengue infection.

Study Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Selangor
      • Ampang, Selangor, Malaysia
        • Recruiting
        • Ampang Hospital
        • Contact:
        • Principal Investigator:
          • Rosaida Mohammad Said
        • Principal Investigator:
          • Ching Soong Khoo
        • Principal Investigator:
          • Melor Mohd Mansor
      • Ampang, Selangor, Malaysia
        • Recruiting
        • Klinik Kesihatan Ampang (Ampang Health Clinic)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients will be recruited from primary care and followed up in the hospital if they were admitted.

Description

Inclusion Criteria:

  • Participants who are age 15 or more.
  • Participants must be recruited within the first three days of fever.
  • Positive dengue by NS1Ag. Confirmed later on by paired dengue IgM/IgG.
  • Final diagnosis of severe dengue or non-severe dengue.

Exclusion Criteria:

  • Participants who are less than 15 years old.
  • Pregnant mothers.
  • Participants should not have autoimmune disorder, haematological disorder, cancer, cardiovascular disease, on long term warfarin and aspirin.
  • Participants who have been previously treated with dengue infection (secondary dengue infection will be excluded by dengue IgM/IgG).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity (%) of biomarkers (PTX3 and VEGF)
Time Frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
upon study completion, 3 years
Specificity (%) of biomarkers (PTX3 and VEGF)
Time Frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
upon study completion, 3 years
Positive predictive value (%) of biomarkers (PTX3 and VEGF)
Time Frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
upon study completion, 3 years
Negative predictive value (%) of biomarkers (PTX3 and VEGF)
Time Frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
upon study completion, 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of routine blood parameters with PTX 3 and VEGF.
Time Frame: upon study completion, 3 years
Pearson's/Spearmann correlation routine blood parameters (ALT, AST, PLT count, HCT and WBC count) with the biomarkers to identify possible prognostic value.
upon study completion, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Tunku Abdul Rahman

Collaborators

Ministry of Health, Malaysia

Investigators

  • Principal Investigator: Gary Low, Universiti Tunku Abdul Rahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (ESTIMATE)

November 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-15-1045-25937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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