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

Canadian Rotavirus Surveillance Through the Immunization Monitoring Program Active (IMPACT): Assessment of Hospitalizations and Emergency Department Visits - the Impact of Publicly Funded Vaccine Programs in Canada

• 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.

Study Overview

• Status: Recruiting
• Conditions: Viral Gastroenteritis Due to Rotavirus

Detailed Description

This study has the ability to provide contemporary Canadian data on the two of the most important outcome measures for effectiveness of rotavirus vaccine: hospital admissions and emergency department visits. The extended time period that already exists prior to vaccine implementation (2005 to 2017) will provide longterm baseline data with which to compare disease burden from 2012 to 2022.

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.

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Nicole Le Saux, MD; Phone Number: 2651 613-737-7600; Email: lesaux@cheo.on.ca
• Study Contact Backup: Name: Melanie Laffin Thibodeau; Phone Number: 239 (613) 526-9397; Email: melaniel@cps.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital
    • Edmonton, Alberta, Canada, T6G 1C9
      • Recruiting
      • Stollery Children's Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • Recruiting
      • Bc Children'S Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Recruiting
      • Winnipeg Children's Hospital
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Recruiting
      • Janeway Children's Health and Rehabilitation Center
      • Principal Investigator: Cheryl Foo, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K6R8
      • Recruiting
      • IWK Health Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Recruiting
      • Children's Hospital of Eastern Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Principal Investigator: Shaun Morris, MD
  • Quebec
    • Montreal, Quebec, Canada, H3H 1P3
      • Recruiting
      • Montreal Children's Hospital
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine hospital
    • Ste Foy, Quebec, Canada, G1V 4G2
      • Recruiting
      • Centre Mère-Enfant de Québec -Pavillon CHUL
      • Principal Investigator: Roseline Thibeault, MD
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Recruiting
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children age 0-16 admitted to the participating IMPACT hospitals (to December 31, 2020) with confirmation of positive stool samples.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Rotavirus; - Children (0-16 years of age)admitted to hospital (through to December 31, 2020)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
- The number of hospital acquired rotavirus infections in children compared pre- and post immunization burden across the network.	Described in the title	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	Described in the title	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.

Collaborators and Investigators

• Sponsor: Canadian Paediatric Society
• Investigators: Principal Investigator: Nicole Le Saux, MD, Children's Hospital of Eastern Ontario

Publications and helpful links

Helpful Links

• IMPACT general web site

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 4, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Gastroenteritis; Surveillance; Rotavirus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: ROTA 2010-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No