NOSO-COVID: COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05411562
Collaborator
Fonds de la Recherche en Santé du Québec (Other), Canadian Institutes of Health Research (CIHR) (Other)
150
1
37.7
4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: SARS-CoV-2 genomic sequencing

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
On-Demand Point-of-Care SARS-CoV-2 Genomic Sequencing to Support Nosocomial Outbreak Investigations: A Prospective Molecular Epidemiology Study in Montreal
Actual Study Start Date :
Nov 9, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Outbreak control measures improvement [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Hospitalized in the institution during the study period

  • Healthcare workers in the institution during the study period

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de l'Université de Montréal Montréal Quebec Canada

Sponsors and Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)
  • Fonds de la Recherche en Santé du Québec
  • Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Simon Grandjean Lapierre, MD MSc FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT05411562
Other Study ID Numbers:
  • NOSO-COVID-2021-9253, 20.270
First Posted:
Jun 9, 2022
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022