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

NCT04184336

Last updated date
Study Location
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Contact
613-526-9397

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Meningococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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 -

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Invasive Meningococcal DiseaseEnhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
NCT04184336
  1. Calgary, Alberta
  2. Edmonton, Alberta
  3. Vancouver, British Colombia
  4. Winnipeg, Manitoba
  5. Saint John's, Newfoundland and Labrador
  6. Halifax, Nova Scotia
  7. Ottawa, Ontario
  8. Toronto, Ontario
  9. Montréal, Quebec
  10. Montréal, Quebec
  11. Québec, Quebec
  12. Saskatoon, Saskatchewan
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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
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, 2020.
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
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any person admitted with confirmation of an invasive meningococcal infection at all participating Centers across Canada
Condition Invasive Meningococcal Disease
Intervention Other: surveillance
Study Groups/Cohorts Persons of all ages
Persons of all ages admitted between January 1, 2016 and December 31, 2020 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
Intervention: Other: surveillance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 28, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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 -
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Melanie Laffin Thibodeau613-526-9397 ext 239[email protected]
Contact: Marie Adele Davis613-526-9397[email protected]
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04184336
Other Study ID Numbers MENING
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party Canadian Paediatric Society
Study Sponsor Canadian Paediatric Society
Collaborators
  • Pfizer
  • GlaxoSmithKline
Investigators Not Provided
PRS Account Canadian Paediatric Society
Verification Date December 2019