An Open, Prospective, Non-prophylactic, Non Therapeutic Study for the Detection and Characterisation of Varicella Zoster Virus Collected From Dermal Lesions of Patients Who Are Diagnosed of Having Varicella/Breakthrough Varicella
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
研究概览
简要总结
This study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. The results of this study will provide basic scientific information about chickenpox disease.
详细描述
The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Varicella Group
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
干预措施: Collection of clinical samples (Procedure)
结局指标
主要结局
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
时间窗: At Visit 1 (Day 0)
The estimated means of the viral load in log10 values for each storage condition (dry and liquid) and each type of sample are presented with 95% confidence intervals
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
时间窗: At Visit 1 (Day 0)
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by storage conditions (dry, liquid). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
时间窗: At Visit 1 (Day 0)
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by sample types (papule swab, vesicle fluid and vesicle swab). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
次要结局
未报告次要终点