NCT04184336

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

7 years

First QC Date

November 28, 2019

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Laboratory confirmed invasive meningococcal cases.

    Laboratory confirmed invasive meningococcal cases.

    End of 2021

Study Arms (1)

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

Interventions

Persons of all ages

Eligibility Criteria

Age1 Minute+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any person admitted with confirmation of an invasive meningococcal infection at all participating Centers across Canada

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, T6G 1C9, Canada

RECRUITING

BC Children's Hospital

Vancouver, British Colombia, V5Z 4H4, Canada

RECRUITING

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

Eastern Health Janeway Children's and Rehabilitation Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

IWK Health Centre

Halifax, Nova Scotia, B3K6R8, Canada

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

CHU- Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Centre Mere-Enfant Soleil CHU de Quebec

Québec, Quebec, G1V 4G2, Canada

RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

RECRUITING

McMaster's Children Hospital

Hamilton, L8S4K1, Canada

RECRUITING

Related Links

Central Study Contacts

Melanie Laffin Thibodeau

CONTACT

Marie Adele Davis

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 3, 2019

Study Start

January 1, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations