The Use of Biomarkers in Predicting Dengue Outcome

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

UNKNOWN

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Dengue

Keywords

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Pentraxin 3 Vascular Endothelial Growth Factor dengue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Gary Kim Kuan Low

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Low

Role: PRINCIPAL_INVESTIGATOR

Universiti Tunku Abdul Rahman

Locations

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Ampang Hospital

Ampang, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Ampang (Ampang Health Clinic)

Ampang, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Gary Low, MPH

Role: CONTACT

Phone: +60123150115

Email: [email protected]

Facility Contacts

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Ridzuan Isa

Role: primary

Hanif Zailani, MPH