Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
NCT04184336
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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 -
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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| Descriptive Information | |||||||||
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| 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, 2022. | ||||||||
| Detailed Description | The objectives are 3-fold, including:
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| 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, 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 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 | 400 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2022 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (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
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Canadian Paediatric Society | ||||||||
| Study Sponsor | Canadian Paediatric Society | ||||||||
| Collaborators | Pfizer | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Canadian Paediatric Society | ||||||||
| Verification Date | March 2021 | ||||||||