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COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05411562
Acronym
NOSO-COVID
Enrollment
150
Registered
2022-06-09
Start date
2020-11-09
Completion date
2023-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Molecular Sequence Variation, Nosocomial Infection

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.

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.

Interventions

DIAGNOSTIC_TESTSARS-CoV-2 genomic sequencing

SARS-CoV-2 viral genomic sequencing and phylogenetic analyses

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Outbreak control measures improvementThrough study completion, an average of 2 yearsCollaborative (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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026