UnknownNot Applicable

Canadian Rotavirus Surveillance Through the Immunization Monitoring Program Active (IMPACT)

Canada2,500 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range1 Minute – 16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

There are two parts to this criteria- Hospital admission surveillance (to December 31, 2019); and genotype surveillance (to December 31, 2020) Hospital admission surveillance: Inclusion Criteria: * 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 Exclusion criteria * 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.

What they're measuring

- Changes in rotavirus hospitalization rates in 12 pediatric hospitals in Canada pre- and post rotavirus vaccine implementation within publicly funded provincial programs

Timeframe: 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

Trial details

NCT IDNCT01633190

SponsorCanadian Paediatric Society

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

Contact for this trial

Nicole Le Saux, MD

613-737-7600 lesaux@cheo.on.ca

View on ClinicalTrials.gov More Viral Gastroenteritis Due to Rotavirus trials