Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Measurement of the presence (with RT-PCR) of ZIKV in semen
研究概览
简要总结
In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.
详细描述
In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.
Knowledge of the possible presence, infectivity and persistence of ZIKV in semen will provide evidence-based data for
- estimating of the risk of sexual transmission of ZIKV in the general population
- antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
- advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
- strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
- advice on gamete cryopreservation
- optimising investigations for diagnosis of ZIKV in males.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged 18-50 years
- •ZIKV symptoms within the preceding thirty days
- •Confirmed ZIKV infection (WHO criteria)
- •Able to ejaculate to produce a semen sample
排除标准
- •Current urological malignancy
结局指标
主要结局
Measurement of the presence (with RT-PCR) of ZIKV in semen
时间窗: 6 months
次要结局
- Measurement of the viral load (with ct values) of ZIKV in semen(6 months)