Clinical trial NCT02606019: The Use of Biomarkers in Predicting Dengue Outcome
Official title: The Use of Biomarkers in Predicting Dengue Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dengue
Keywords: Pentraxin 3
Vascular Endothelial Growth Factor
dengue
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2015-11-17
Enrollment: 108
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients will be recruited from primary care and followed up in the hospital if they were admitted.

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Sensitivity (%) of biomarkers (PTX3 and VEGF)
timeFrame: upon study completion, 3 years
measure: Specificity (%) of biomarkers (PTX3 and VEGF)
timeFrame: upon study completion, 3 years
measure: Positive predictive value (%) of biomarkers (PTX3 and VEGF)
timeFrame: upon study completion, 3 years
measure: Negative predictive value (%) of biomarkers (PTX3 and VEGF)
timeFrame: upon study completion, 3 years
Secondary outcomes:
measure: Correlation of routine blood parameters with PTX 3 and VEGF.
timeFrame: upon study completion, 3 years
Other outcomes:
Locations:
city: Ampang
country: Malaysia
facility: Ampang Hospital
state: Selangor
city: Ampang
country: Malaysia
facility: Klinik Kesihatan Ampang (Ampang Health Clinic)
state: Selangor
Study officials:
affiliation: Universiti Tunku Abdul Rahman
name: Gary Low
role: PRINCIPAL_INVESTIGATOR
References: