Laboratory Diagnosis and Prognosis of Severe Dengue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,100
- 试验地点
- 1
- 主要终点
- Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
研究概览
简要总结
A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho Chi Minh City and Tien Giang province, Viet Nam.
Different blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to severe disease.
详细描述
In a prospective study in the outpatients department of three large hospitals in Ho Chi Minh City, Viet Nam, we will determine the early diagnostic sensitivity, specificity, positive and negative predictive values of two NS1 diagnostic tests in severe dengue cases.
The study is intended to develop a prognostic algorithm for the early identification of severe dengue cases.
Routine demographic, haematological and biochemical laboratory markers will be utilized to derive a prognostic algorithm that is clinically-useful for guiding patient triage and interventions.
We hope to discover and evaluate new early biomarkers of severe dengue and will evaluate candidate host response molecules and virological markers for their prognostic value.
We further plan to understand the phylogeography of DENV in the super-urban setting of HCMC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of dengue
- •Axillary temperature >=37.5C
- •Less than 72hrs of fever
- •Resident in Ho Chi Minh City
- •1-15 yrs of age
- •Accompanying family member or guardian has a mobile phone
- •Written informed consent
排除标准
- •Any patient who the attending physician believes is unlikely to be able to attend follow-up
- •Any patient in who the attending physician believes another diagnosis is more likely.
结局指标
主要结局
Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
时间窗: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict no dengue infection.
Specificity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
时间窗: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict different dengue serotypes.
Positive predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
时间窗: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict dengue infection.
Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.
时间窗: Within the first 72 hours of fever onset
Percentage of detection assays which correctly predict laboratory-confirmed severe dengue.
次要结局
- Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.(Estimated within 6 days of presentation)
- Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy.(Estimated within 6 days of presentation)
- Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.(Estimated within 6 days of presentation)
- Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.(Estimated within 6 days of presentation)