NCT03204409撤回不适用
Longitudinal Clinical and Virological Study Among Symptomatic Patients With Zika Virus Infection in the City of Sao Paulo, Brazil
University of Heidelberg Medical Center1 个研究点 分布在 1 个国家开始时间: 2018年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- ZIKA Virus Infection
研究概览
简要总结
Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil.
详细描述
- Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil.
- Following enrolment (day 0), patients will be followed up at days 2-3, 7, 14, 21, 30, 90, 180 and 360 with clinical and biological procedures (blood and urine samples).
- For patients with proven ZIKA Virus (ZIKV) infection, follow-up samples will include blood, saliva, urine and genital samples.
- For non-ZIKV infected patients, follow-up samples will include serological monitoring at days 14, 30, 180 and 360, and for men, possible assessment of genital fluids at day 180.
- All patients will be evaluated for impact on disability up to one year. Household adult contacts of ZIKV patients will be invited for ZIKV evaluation including collection of blood and urine samples.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rash or Fever illness
- •within 72 hours of symptom onset
排除标准
- •presence of symptoms or complications indicative of a bacterial infection
结局指标
主要结局
ZIKA Virus Infection
时间窗: up to one year
Clinical Characterization
DENGUE Virus Infection
时间窗: up to one year
Clinical Characterization
Chikungunya Virus Infection
时间窗: up to one year
Clinical Characterization
次要结局
未报告次要终点
研究者
Thomas Jaenisch
Senior Scientist
University of Heidelberg Medical Center
研究点 (1)
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