Clinical trial NCT04184336: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
Official title: IMPACT Project Protocol: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Meningococcal Disease
Lead sponsor: Canadian Paediatric Society
Sponsor class: OTHER
Collaborators: name: Pfizer
name: GlaxoSmithKline
First posted: 2019-12-03
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any person admitted with confirmation of an invasive meningococcal infection at all participating Centers across Canada

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

Eligibility criteria: 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 -

Primary outcomes:
measure: Laboratory confirmed invasive meningococcal cases.
timeFrame: End of 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Colombia
city: Winnipeg
country: Canada
facility: Children's Hospital Research Institute of Manitoba
state: Manitoba
city: Saint John's
country: Canada
facility: Eastern Health Janeway Children's and Rehabilitation Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: CHU- Sainte Justine
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Québec
country: Canada
facility: Centre Mere-Enfant Soleil CHU de Quebec
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Hamilton
country: Canada
facility: McMaster's Children Hospital
Study officials:
References: