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

• Conditions: Invasive Meningococcal Disease
• Interventions: Other: surveillance

• Registration Number: NCT04184336
• Lead Sponsor: Canadian Paediatric Society

Brief Summary

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.

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons of all ages	surveillance	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

Primary Outcome Measures

Name	Time	Method
Laboratory confirmed invasive meningococcal cases.	End of 2021	Laboratory confirmed invasive meningococcal cases.

Trial Locations

Locations (13)

Centre Mere-Enfant Soleil CHU de Quebec; 🇨🇦 Québec, Quebec, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Montreal Children's Hospital; 🇨🇦 Montréal, Quebec, Canada

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

CHU- Sainte Justine; 🇨🇦 Montréal, Quebec, Canada

Children's Hospital Research Institute of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

McMaster's Children Hospital; 🇨🇦 Hamilton, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

BC Children's Hospital; 🇨🇦 Vancouver, British Colombia, Canada

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

Eastern Health Janeway Children's and Rehabilitation Centre; 🇨🇦 Saint John's, Newfoundland and Labrador, Canada