Canadian Rotavirus Surveillance Through the Immunization Monitoring Program Active (IMPACT)
1 other identifier
observational
2,500
1 country
12
Brief Summary
- Rotavirus Hospital Admissions Surveillance
- Retrospective surveillance for 2010 and 2011 for hospital admissions in children aged 0 to 16 years due to rotavirus gastroenteritis will be completed by all centers of the IMPACT (Immunization Monitoring Program, ACTive) pediatric hospital network.
- Prospective surveillance of rotavirus-related admissions for children aged 0 to 16 years was conducted in 2012-20 inclusive and will be performed for an additional 2 years until the end of 2022 at all 12 sites. Surveillance methodology will continue using the same case-finding strategy and the same case report form as in past surveillance (Case reporting is done electronically.
- Emergency Department Burden of Disease Case finding for all-cause diarrheal illness using ICD codes was undertaken prospectively for 2012 to 2014 and will not continue in the years 2015-17 inclusive. Systematic stool sampling was carried out for cases of gastroenteritis in children \< 5 years of age presenting to the ED departments at the IMPACT hospitals in 2012 and 2013 and 5 of the 12 center hospitals in 2014. This component will not continue in to the 2015-17 protocol study years. However the admitted cases presenting to the IMPACT center hospitals with positive rotavirus will be reported and stool samples saved for genotyping at a later date.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 22, 2021
March 1, 2021
10.8 years
June 12, 2012
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
- Changes in rotavirus hospitalization rates in 12 pediatric hospitals in Canada pre- and post rotavirus vaccine implementation within publicly funded provincial programs
Described In the title
Patients are identified on admission starting January 1, 2018. The surveillance period begins when rotavirus is identified and continues until the patients are discharged (average 3-4 days). The study end date is December 31, 2020
Secondary Outcomes (2)
- The number of hospital acquired rotavirus infections in children compared pre- and post immunization burden across the network.
Patients are enrolled when rotavirus is identified on a hospitalized patient. The patient is followed until discharge or symptoms of infection have ceased (average 5 days). Enrolment starts January 1, 2012 and ends December 31, 2020.
- The most common rotavirus genotypes in hospitalized patients
Stool specimens from 2012 to 2020 will be collected at the time of laboratory diagnosis. Collection of isolates starts January 1, 2012 and continues to December 2020.
Study Arms (1)
Rotavirus
\- Children (0-16 years of age)admitted to hospital (through to December 31, 2020)
Eligibility Criteria
Children age 0-16 admitted to the participating IMPACT hospitals (to December 31, 2020) with confirmation of positive stool samples.
You may qualify if:
- Age 0 to 16 years of age.
- Inpatient status at the IMPACT hospital
- Acute onset of symptoms of acute gastroenteritis with or without diarrheal stools, with or without vomiting, with or without fever.
- Laboratory confirmation of rotavirus in stool specimens or autopsy tissue sample with the use of antigen detection methods (enzyme linked immunoassay \[ELISA\] or immunochromatographic methods) or electron microscopy or molecular (PCR) diagnosis in a stool specimen taken within 14 days after the onset of gastrointestinal symptoms. Cases identified by autopsy must have had gastrointestinal symptoms before death.
- Referred cases of rotavirus infections that have laboratory confirmation from another institution using the same criteria as above
You may not qualify if:
- Non-laboratory confirmed diagnosis.
- Clinical data is not accessible to the nurse monitor.
- Incidental findings of rotavirus in patients admitted to hospital without acute gastrointestinal symptoms.
- Rotavirus Genotype Surveillance - on stool sample already obtained for hospital admission purposes (not additional for the surveillance).
- \- Rotavirus identification: Rotavirus identification at sites will be accomplished by rotavirus antigen detected by EIA (Enzyme Immuno Assay) or electron microscopy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9, Canada
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Winnipeg Children's Hospital
Winnipeg, Manitoba, R3E 3P4, Canada
Janeway Children's Health and Rehabilitation Center
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
IWK Health Centre
Halifax, Nova Scotia, B3K6R8, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3, Canada
CHU Sainte-Justine Hospital
Montreal, Quebec, H3T 1C5, Canada
Centre Mère-Enfant de Québec -Pavillon CHUL
Ste Foy, Quebec, G1V 4G2, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Le Saux, MD
Children's Hospital of Eastern Ontario
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
July 4, 2012
Study Start
March 1, 2012
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 22, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share