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

Invasive Meningococcal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04184336
• Other study ID #: MENING
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Canadian Paediatric Society
• Contact: Melanie Laffin Thibodeau
• Phone: 613-526-9397
• Email: melaniel[@]cps.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Invasive Meningococcal Disease
• Meningococcal Infections

Intervention

Other:
• surveillance

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster's Children Hospital	Hamilton
Canada	CHU- Sainte Justine	Montréal	Quebec
Canada	Montreal Children's Hospital	Montréal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Centre Mere-Enfant Soleil CHU de Quebec	Québec	Quebec
Canada	Eastern Health Janeway Children's and Rehabilitation Centre	Saint John's	Newfoundland and Labrador
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Colombia
Canada	Children's Hospital Research Institute of Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Paediatric Society	GlaxoSmithKline, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory confirmed invasive meningococcal cases.	Laboratory confirmed invasive meningococcal cases.	End of 2021

External Links

•   Description IMPACT public website