Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada

IMPACT Project Protocol: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada

Active metropolitan area surveillance for hospital admissions related to invasive infection with Neisseria meningitidis will be conducted at the 12 centers in the IMPACT network in collaboration with Public Health officials, local infection specialists and infection control practitioners during the interval from January 1, 2016 to December 31, 2022.

Study Overview

• Status: Recruiting
• Conditions: Invasive Meningococcal Disease
• Intervention / Treatment: Other: surveillance

Detailed Description

The objectives are 3-fold, including:

1. description of affected children and adults and the nature and outcome of the infection episodes
2. incidence rate determination in defined populations, by age, serogroup and study year
3. detailed study of the organisms recovered from cases

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Melanie Laffin Thibodeau; Phone Number: 239 613-526-9397; Email: melaniel@cps.ca
• Study Contact Backup: Name: Marie Adele Davis; Phone Number: 613-526-9397; Email: madavis@cps.ca

Study Locations

• Canada
  • Hamilton, Canada, L8S4K1
    • Recruiting
    • McMaster's Children Hospital
    • Contact: Jeffrey Pernica, MD
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital
      • Contact: Taj Jadavji, MD
    • Edmonton, Alberta, Canada, T6G 1C9
      • Recruiting
      • Stollery Children's Hospital
      • Contact: Wendy Vaudry, MD
  • British Colombia
    • Vancouver, British Colombia, Canada, V5Z 4H4
      • Recruiting
      • BC Children's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Recruiting
      • Children's Hospital Research Institute of Manitoba
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Recruiting
      • Eastern Health Janeway Children's and Rehabilitation Centre
      • Contact: Natalie Bridger, MD
      • Principal Investigator: Natalie Bridger, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K6R8
      • Recruiting
      • IWK Health Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Recruiting
      • Children's Hospital of Eastern Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Principal Investigator: Shaun Morris
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Montreal Children's Hospital
      • Contact: Jesse Papenburg, MD
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU- Sainte Justine
      • Contact: Marc Lebel, MD
    • Québec, Quebec, Canada, G1V 4G2
      • Recruiting
      • Centre Mere-Enfant Soleil CHU de Quebec
      • Principal Investigator: Roseline Thibeault
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Recruiting
      • Royal University Hospital
      • Contact: Ben Tan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any person admitted with confirmation of an invasive meningococcal infection at all participating Centers across Canada

Description

Inclusion Criteria:Neisseria meningitidis isolated or detected by PCR from a normally sterile body site or fluid, such as blood, CSF, joint fluid, pleural, peritoneal, pericardial fluid or tissue biopsy -

Exclusion Criteria:patients diagnosed based only on

1. clinical signs, gram stain, or antigen test
2. meningococci isolated only from respiratory tract, including conjunctiva, sinuses, middle ear/mastoid, throat, peritonsillar abscess, cervical lymph node, tracheal aspirate, bronchial lavage etc -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons of all ages; Persons of all ages admitted between January 1, 2016 and December 31, 2022 with a positive result of Neisseria meningitidis isolated or detected by PCR from a normal sterile site, such as blood, CSF, joint fluid, pleural, peritoneal, pericardial fluid or tissue biopsy	Other: surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory confirmed invasive meningococcal cases.	Laboratory confirmed invasive meningococcal cases.	End of 2021

Collaborators and Investigators

• Sponsor: Canadian Paediatric Society
• Collaborators: GlaxoSmithKline; Pfizer

Publications and helpful links

Helpful Links

• Description IMPACT public website

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (ACTUAL): December 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: MENING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No