Clinical Trials Directory

Trials / Completed

CompletedNCT05411562

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
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSARS-CoV-2 genomic sequencingSARS-CoV-2 viral genomic sequencing and phylogenetic analyses

Timeline

Start date
2020-11-09
Primary completion
2023-12-31
Completion
2023-12-31
First posted
2022-06-09
Last updated
2024-09-19

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05411562. Inclusion in this directory is not an endorsement.