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临床试验/NCT04164576
NCT04164576尚未招募不适用

Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
BKV viral load in urine (viruria) and in plasma (viremia)

研究概览

简要总结

BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.

The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

BKV viral load in urine (viruria) and in plasma (viremia)

时间窗: 3 years

In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.

次要结局

  • Quantification of anti-BKV neutralizing antibodies(3 years)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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