跳至主要内容
临床试验/NCT05411562
NCT05411562招募中不适用

On-Demand Point-of-Care SARS-CoV-2 Genomic Sequencing to Support Nosocomial Outbreak Investigations: A Prospective Molecular Epidemiology Study in Montreal

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Outbreak control measures improvement

研究概览

简要总结

This is a tertiary care hospital-based prospective molecular epidemiology study in Montreal, Canada. When nosocomial transmission was suspected by local infection control teams' investigations, SARS-CoV-2 viral genomic sequencing was performed locally for all putative outbreak cases and contemporary controls. Molecular and conventional epidemiology data were confronted in real time to improve understanding of COVID-19 transmission and reinforce or adapt prevention measures.

详细描述

This study will include infected healthcare workers (HCW) and patients for whom a nosocomial infection in CHUM is suspected. The CHUM laboratory is responsible for COVID-19 diagnostic testing in all eligible HCW and patients. After initial diagnosis on standard PCR testing, samples are maintained at -80. Viral RNA is extracted and next-generation sequencing of the viral genome is performed using Nanopore long read sequencing platform. Preliminary data suggest that SARS-CoV-2 has a "molecular clock" of 2 single nucleotide polymorphism (SNP) per month. The analysis and between-isolate comparaison of those SNP among epidemiologically related cases will allow to support or refute the hypothesis of person to person nosocomial transmission. All infected patients will be matched 1:1 with contemporary community cases to provide a viral genome back catalog and better contextualize molecular epidemiology analyses. Molecular clusters will be reported to infection prevention and control teams and resulting interventions will be monitored.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized in the institution during the study period
  • Healthcare workers in the institution during the study period

排除标准

  • 未提供

结局指标

主要结局

Outbreak control measures improvement

时间窗: Through study completion, an average of 2 years

Collaborative (infection control and molecular epidemiology teams) resolution of putative outbreaks. Transmission is either refuted or further supported by molecular analyses. Additional investigation efforts are discontinued or necessary corrective measures are implemented.

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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