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

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ClinicalTrials.gov Identifier: NCT01633190
Recruitment Status : Recruiting
First Posted : July 4, 2012
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):

Study Description
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 2012-14 inclusive and will be performed for an additional three years, 2015, 2016 and 2017 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.

Condition or disease
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 2011) will provide longterm baseline data with which to compare disease burden from 2012 to 2017.

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 Design

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: 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
Study Start Date : March 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

  • Children (0-16 years of age)admitted to hospital (2010-17)
  • Children (0-5 years of age) presenting to the emergency department with gastroenteritis (2010-14)

Outcome Measures

Primary Outcome Measures :
  1. - Changes in rotavirus hospitalization rates in 12 pediatric hospitals in Canada pre- and post rotavirus vaccine implementation 2005 to 2017 [ Time Frame: Patients are identified on admission starting January 1, 2012. 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 2017 ]

Secondary Outcome Measures :
  1. - The number of hospital acquired rotavirus infections in children compared pre- and post immunization burden across the network. [ Time Frame: 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, 2017. ]
  2. - The most common rotavirus genotypes 2012 to 2017 for hospitalized patients and those seen in the Emergency Departments (to December 31, 2014). [ Time Frame: Stool specimens from 2012 to 2017 will be collected at the time of laboratory diagnosis. A final report on the typing of isolates will be done in June 2018. Collection of isolates starts January 1, 2012 and continues to December 2017. ]
  3. - Trends in Emergency Department visits for gastroenteritis from 2010 to 2014 at selected IMPACT centers. [ Time Frame: The number of visits will be obtained from January 2012 to December 2014. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children age 0-16 admitted to the participating IMPACT hospitals (to December 31, 2017) with confirmation of positive stool samples; and children age 0-5 years presenting to the emergency departments (to December 31, 2014) of the participating IMPACT hospitals with a diagnosis of gastroenteritis.

There are three parts to this criteria- Hospital admission surveillance (to December 2017); Emergency Department determination of disease burden (To December 2014); and genotype surveillance (to December 2017)

A. 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.

B. Emergency Department Visits for determination of disease burden and determination proportion of rotavirus infections

Inclusion criteria:

  • The number of children under 5 years of age discharged from the ED with a ICD code diagnosis of diarrheal illness.
  • Parents of children who present to the emergency departments at the participating centers will be asked to allow their child's stool sample to be tested for rotavirus according to the guidelines set out by the respective Ethics review boards at each IMPACT center.

C: Rotavirus genotyping

C. Rotavirus Genotype Surveillance - which includes both the specimens from A and B above.

Exclusion criteria:

- No stool sample

Inclusion criteria:

  • Rotavirus identification: Rotavirus identification at sites will be accomplished by rotavirus antigen detected by EIA (Enzyme Immuno Assay) or electron microscopy.
  • At all hospitals, patients admitted to hospital with acute diarrheal illness have stool specimens sent for viral testing. Stool specimens from admitted patients will be saved. The rotavirus positive specimens from patients presenting to the ED and who have consented to stool specimen that test positive for rotavirus will also be saved.
  • A convenience sample of rotavirus positive specimens will be forwarded for genotype testing to the National microbiology laboratory. All rotavirus positive stools from the ED and hospitalized cases will be line listed by date of collection or diagnosis. At the end of the season, depending on the number of positives, the sites will select every second, third or fourth specimen (and so forth) to forward to the genotyping laboratory in order to equal 20 specimens per site and ensure equal representation for all time periods of the rotavirus season and from sites of acquisition (ED and hospitalized cases).
  • This will yield a maximum of 280 samples per year. These stools will be stored frozen to -80°C for genotype analysis. Nine provinces will send isolates directly to the National Microbiology Laboratory under the direction of Dr. Timothy Booth for genotype analysis. The two IMPACT centers in Montreal will do genotype analysis in their provincial laboratory and will subsequently share the data with the Vaccine Evaluation Center in Vancouver. A proportion of the strains will be exchanged between both laboratories in order to validate results.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633190

Contact: Nicole Le Saux, MD 613-737-7600 ext 2651 lesaux@cheo.on.ca
Contact: Heather Samson, BScN RN 902-470-8182 heather.samson@iwk.nshealth.ca

Canada, Alberta
Alberta Children`s Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Principal Investigator: Taj Jadavji, MD         
Stollery Children`s Hospital Recruiting
Edmonton, Alberta, Canada, T6G 1C9
Principal Investigator: Wendy Vaudry, MD         
Canada, British Columbia
BC Children`s Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Manish Sadarangani         
Principal Investigator: Manish Sadarangani, MD         
Canada, Manitoba
Winnipeg Children`s Hospital Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Joanne Embree, MD         
Principal Investigator: Joanne Embree, MD         
Canada, Newfoundland and Labrador
Janeway Children`s Health and Rehabilitation Center Recruiting
St. John`s, Newfoundland and Labrador, Canada, A1B 3V6
Principal Investigator: Natalie Bridger, MD         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K6R8
Contact: Karina Top, MD         
Principal Investigator: Karina Top, MD         
Canada, Ontario
Children`s Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Nicole Le Saux, MD         
Principal Investigator: Nicole Le Saux, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Shaun Morris, MD         
Principal Investigator: Shaun Morris, MD         
Canada, Quebec
Montreal Children`s Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Principal Investigator: Marie-Astrid Lefebvre, MD         
CHU Sainte-Justine Hospital Recruiting
Montréal, Quebec, Canada, H3T 1C5
Principal Investigator: Marc Lebel, MD         
Centre Mère-Enfant de Québec -Pavillon CHUL Recruiting
Ste Foy, Quebec, Canada, G1V 4G2
Contact: Roseline Thibeault, MD         
Principal Investigator: Roseline Thibeault, MD         
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Principal Investigator: Ben Tan, MD         
Sponsors and Collaborators
Canadian Paediatric Society
Principal Investigator: Nicole Le Saux, MD Children`s Hospital of Eastern Ontario
More Information

Additional Information:
Responsible Party: Canadian Paediatric Society
ClinicalTrials.gov Identifier: NCT01633190     History of Changes
Other Study ID Numbers: ROTA 2010-2017
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Canadian Paediatric Society:

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Immunologic Factors
Physiological Effects of Drugs