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临床试验/NCT02606019
NCT02606019Unknown不适用

The Use of Biomarkers in Predicting Dengue Outcome

Universiti Tunku Abdul Rahman2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
108
试验地点
2
主要终点
Sensitivity (%) of biomarkers (PTX3 and VEGF)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Sensitivity (%) of biomarkers (PTX3 and VEGF)

时间窗: 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.

Specificity (%) of biomarkers (PTX3 and VEGF)

时间窗: 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.

Positive predictive value (%) of biomarkers (PTX3 and VEGF)

时间窗: 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.

Negative predictive value (%) of biomarkers (PTX3 and VEGF)

时间窗: 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.

次要结局

  • Correlation of routine blood parameters with PTX 3 and VEGF.(upon study completion, 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gary Kim Kuan Low

Dr.

Universiti Tunku Abdul Rahman

研究点 (2)

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