Canadian Rotavirus Surveillance Through the Immunization Monitoring Program Active (IMPACT)
NCT ID: NCT01633190
Last Updated: 2021-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
2500 participants
OBSERVATIONAL
2012-03-31
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study
NCT03271593
Vaccine Effectiveness of RV1 in a Naïve Population
NCT01467037
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
NCT00740935
Surveillance of Rotavirus Gastroenteritis in Children <5 Years
NCT01363726
Impact of Rotavirus Vaccine Introduction for South Australian Children
NCT01472575
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The major advantages to this study are that surveillance occurs at the same hospitals and the same methodology and CRF has been used since 2005. This will ensure reliability and consistency in the surveillance study. The national data set captures patients from age group 0 to 16 years in 12 centers across the country. The retrospective and prospective studies will be in a unique position to capture all children admitted to the 12 pediatric hospitals in Canada. Since reliance on discharge codes alone may underestimate gastroenteritis due to rotavirus, laboratory surveillance coupled with medical record review will ensure the complete capture of the true disease burden. Data on the health status of children will facilitate the evaluation of children who are medically fragile for which rotavirus infections may be more significant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rotavirus
\- Children (0-16 years of age)admitted to hospital (through to December 31, 2020)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
1 Minute
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Paediatric Society
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicole Le Saux, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Eastern Ontario
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Center
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
CHU Sainte-Justine Hospital
Montreal, Quebec, Canada
Centre Mère-Enfant de Québec -Pavillon CHUL
Ste Foy, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Manish Sadarangani
Role: primary
Joanne Embree, MD
Role: primary
Karina Top, MD
Role: primary
Nicole Le Saux, MD
Role: primary
Shaun Morris, MD
Role: primary
Roseline Thibeault, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
IMPACT general web site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ROTA 2010-2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.