COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations

NCT05411562 | Completed

• 1 other identifier: 20.270
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Molecular Sequence Variation; Nosocomial Infection

Outcome Measures

Primary Outcomes (1)

• Outbreak control measures improvement

  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.

  Through study completion, an average of 2 years

Interventions

SARS-CoV-2 genomic sequencing DIAGNOSTIC_TEST

SARS-CoV-2 viral genomic sequencing and phylogenetic analyses

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and healthcare workers in the institution during the study period.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

Related Publications (1)

• Benoit P, Jolicoeur G, Point F, Soucy C, Normand K, Morency-Potvin P, Gagnon S, Kaufmann DE, Tremblay C, Coutlee F, Harrigan PR, Hardy I, Smith M, Savard P, Grandjean Lapierre S. On-demand, hospital-based, severe acute respiratory coronavirus virus 2 (SARS-CoV-2) genomic epidemiology to support nosocomial outbreak investigations: A prospective molecular epidemiology study. Antimicrob Steward Healthc Epidemiol. 2023 Mar 8;3(1):e45. doi: 10.1017/ash.2023.119. eCollection 2023.

  PMID: 36960087 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs from patients and healthcare workers. Primary samples that are positive on PCR or SARS-CoV-2 are retained.

MeSH Terms

Conditions

COVID-19; Cross Infection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Grandjean Lapierre, MD MSc FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 9, 2022
• Study Start: November 9, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)