跳至主要内容
临床试验/NCT04056546
NCT04056546已完成不适用

Interest of Rapid Typing in Adenovirus Infections: Sensitivity and Specificity, Study of the Association Clinical Characteristics and Viral Type.

University Hospital, Bordeaux0 个研究点目标入组 296 人开始时间: 2012年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
296
主要终点
Type viral characterization (scale A to G)

研究概览

简要总结

Proposal of a "rapid typing" technique by a new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in Adenovirus infections.

详细描述

Adenoviruses cause many infections, mainly respiratory and gastroenteric, in pediatrics.

They also behave as opportunistic agents in 10% of hematopoietic stem cell recipients. In these immunocompromised persons, these infections are all the more frequent as the graft is of placental origin and the recipient a child (20%). They are then willingly disseminated and potentially deadly; their treatment is based on cidofovir, a viral agent that is very sensitive to handling.

Adenoviruses, which have a high genetic diversity, are classified into 7 types. According to some observations, still limited, some types of Adenovirus would show a higher pathogenicity (types C and A). Thus, viral typing may be prognostic for immunocompromised patients, justifying the initiation of an earlier specific treatment when identifying certain more pathogenic viral types, in addition to measuring the viral load, already performed by quantitative PCR.

For this purpose, this study proposes a "fast typing" technique by new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing, reference method.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Samples identified as positive in Adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).

结局指标

主要结局

Type viral characterization (scale A to G)

时间窗: At the screening

sensitivity and specificity of the rapid typing technique, expressed for each strain, relative to the reference method (nucleotide sequencing), among initial diagnostic samples of viral load\> 10 \^ 4 / mL.

次要结局

未报告次要终点

研究者

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

相似试验