Invasive Meningococcal DiseaseNCT04184336
Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
An observational study of Invasive Meningococcal Disease, run by Canadian Paediatric Society at 13 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Invasive Meningococcal Disease
- What is being tested?
- surveillance
- How many people
- 400 participants
- Where
- 13 sitesCanada
- Study dates
- Jan 2016to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any person admitted with confirmation of an invasive meningococcal infection at all participating Centers across Canada
Who may be able to join
None listed.
Who cannot join
- clinical signs, gram stain, or antigen test
- meningococci isolated only from respiratory tract, including conjunctiva, sinuses, middle ear/mastoid, throat, peritonsillar abscess, cervical lymph node, tracheal aspirate, bronchial lavage etc -
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites, 13 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Taj Jadavji, MD
Taj Jadavji, MD
- Recruiting
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9
Wendy Vaudry, MD
Wendy Vaudry, MD
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K6R8
Karina Top, MD
Karina Top, MD
- Recruiting
McMaster's Children Hospital
Hamilton, L8S4K1
Jeffrey Pernica, MD
- Recruiting
CHU- Sainte Justine
Montreal, Quebec, H3T 1C5
Marc Lebel, MD
Marc Lebel, MD
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Jesse Papenburg, MD
Jesse Papenburg, MD
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Nicole Le Saux, MD
Nicole Le Saux, MD
- Recruiting
Centre Mere-Enfant Soleil CHU de Quebec
Québec, Quebec, G1V 4G2
Roseline Thibeault, MD
Roseline Thibeault
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Ben Tan
Ben Tan, MD
- Recruiting
Eastern Health Janeway Children's and Rehabilitation Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Natalie Bridger, MD
Natalie Bridger, MD
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Shaun Morris, MD
Shaun Morris
- Recruiting
BC Children's Hospital
Vancouver, British Colombia, V5Z 4H4
Manish Sadarangani
Manish Sadarangani, MD
- Recruiting
Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, R3E 3P4
Joanne Embree, MD
Joanne Embree, MD
About this study
Official title: IMPACT Project Protocol: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
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.
Read the detailed description
The objectives are 3-fold, including:
- description of affected children and adults and the nature and outcome of the infection episodes
- incidence rate determination in defined populations, by age, serogroup and study year
- detailed study of the organisms recovered from cases
- Conditions
- Invasive Meningococcal Disease
- Being tested
- surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveillanceOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory confirmed invasive meningococcal cases.
Laboratory confirmed invasive meningococcal cases.
Measured: End of 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study startJan 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Meningococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Paediatric Society
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184336
- Sponsor's protocol ID
- MENING
- Status last verified
- Apr 2022
- First submitted
- 28 Nov 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT Project Protocol: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
- ClinicalTrials.gov ID
- NCT04184336
- Acronym / sponsor ID
- MENING
- Conditions
- Invasive Meningococcal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Canadian Paediatric SocietyUniversity, hospital or other
- Collaborators
- Pfizer, GlaxoSmithKline
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- description of affected children and adults and the nature and outcome of the infection episodes
- incidence rate determination in defined populations, by age, serogroup and study year
- detailed study of the organisms recovered from cases
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons of all ages | – | Other: surveillancePersons 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 |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any person admitted with confirmation of an invasive meningococcal infection at all participating Centers across Canada
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- clinical signs, gram stain, or antigen test
- meningococci isolated only from respiratory tract, including conjunctiva, sinuses, middle ear/mastoid, throat, peritonsillar abscess, cervical lymph node, tracheal aspirate, bronchial lavage etc -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveillance | Other | Persons of all ages |
Primary outcome
Laboratory confirmed invasive meningococcal cases.
Time frame: End of 2021
Laboratory confirmed invasive meningococcal cases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Description IMPACT public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Meningococcal Disease, run by Canadian Paediatric Society at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Laffin Thibodeau (613-526-9397 ext. 239, melaniel@cps.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory confirmed invasive meningococcal cases. (time frame: End of 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.