The Use of Biomarkers in Predicting Dengue Outcome

NCT02606019 | Unknown

• 1 other identifier: NMRR-15-1045-25937
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Dengue

Keywords

Pentraxin 3; Vascular Endothelial Growth Factor; dengue

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Correlation of routine blood parameters with PTX 3 and VEGF.

  upon study completion, 3 years

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (2)

Ampang Hospital

Ampang, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Ampang (Ampang Health Clinic)

Ampang, Selangor, Malaysia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum/plasma samples

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Gary Low

  Universiti Tunku Abdul Rahman

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Low, MPH

CONTACT

+60123150115; garylowkk@utar.edu.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 17, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

MY (2)