Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,257
- 试验地点
- 10
- 主要终点
- Existence of Ortho-C infection
研究概览
简要总结
The main objective of this study is to evaluate the prevalence and the clinical impact of Orthohepevirus C infection in different human populations, and to determine its zoonotic origin comparing the sequences obtained in both human and animal populations. This is an ambispective study where Orthohepevirus C infection will be evaluated in four high risk human population: i) patients with acute hepatitis, ii) patients with positive IgM antibody against Hepatitis E virus infection with undetectable viral load, iii) HIV infected individuals, and iv) solid organ transplant recipients. Furthermore, we will analyze three animal populations: i) suburban rodents, ii) domestic rodents, iii) wild carnivores. Viral sequences identified in both human and animal populations will be compared to evaluate the zoonotic origin of the infections.
详细描述
To carry out the project a database will be created in electronic format, where the study team will integrate epidemiological, clinical and laboratory tests data of patients. Data will be anonymous and coded by a data manager.
Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin
Secondary objectives are:
- To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
- To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
- To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
- To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
- To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
- To evaluate the prevalence of infection by Ortho-C in wild carnivores
- To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Existence of Ortho-C infection
时间窗: Yearly, up to three years.
The presence of Ortho-C infection is defined by: * HAOD, TrazHE, OrthoC-Tx and Ortho-CoRIS cohorts: presence of RNA-OrthoC in blood. * Ortho-C-Rodent and Ortho-C-Carnivore cohorts: presence of RNA-OrthoC in serum, feces and/or liver tissue * Ortho-C-Domestic-Rodent cohort: presence of RNA-OrthoC in feces.
次要结局
未报告次要终点