The Use of Biomarkers in Predicting Dengue Outcome

Dengue Clinical Trial

Official title:

The Use of Biomarkers in Predicting Dengue Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02606019
• Other study ID #: NMRR-15-1045-25937
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2015
• Last updated: October 24, 2016
• Start date: October 2015
• Est. completion date: October 2019

Study information

• Verified date: October 2016
• Source: Universiti Tunku Abdul Rahman
• Contact: Gary Low, MPH
• Phone: +60123150115
• Email: garylowkk[@]utar.edu.my
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dengue

Locations

Country	Name	City	State
Malaysia	Ampang Hospital	Ampang	Selangor
Malaysia	Klinik Kesihatan Ampang (Ampang Health Clinic)	Ampang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity (%) of biomarkers (PTX3 and VEGF)	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	No
Primary	Specificity (%) of biomarkers (PTX3 and VEGF)	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	No
Primary	Positive predictive value (%) of biomarkers (PTX3 and VEGF)	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	No
Primary	Negative predictive value (%) of biomarkers (PTX3 and VEGF)	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	No
Secondary	Correlation of routine blood parameters with PTX 3 and VEGF.	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	No