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

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ClinicalTrials.gov Identifier: NCT04184336
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Invasive Meningococcal Disease 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

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: IMPACT Project Protocol: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


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



Primary Outcome Measures :
  1. Laboratory confirmed invasive meningococcal cases. [ Time Frame: End of 2021 ]
    Laboratory confirmed invasive meningococcal cases.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any person admitted with confirmation of an invasive meningococcal infection at all participating Centers across Canada
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184336


Contacts
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Contact: Melanie Laffin Thibodeau 613-526-9397 ext 239 melaniel@cps.ca
Contact: Marie Adele Davis 613-526-9397 madavis@cps.ca

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

Documents provided by Canadian Paediatric Society:
Study Protocol: Study protocol  [PDF] October 29, 2020
Study Protocol: ID_NCT04184336  [PDF] March 18, 2021

Additional Information:
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Responsible Party: Canadian Paediatric Society
ClinicalTrials.gov Identifier: NCT04184336    
Other Study ID Numbers: MENING
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningococcal Infections
Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses