Recruiting

Rotavirus Surveillance

Sponsor:

Canadian Paediatric Society

Code:

NCT01633190

Conditions

Viral Gastroenteritis Due to Rotavirus

Eligibility Criteria

Sex: All

Age: 0 - 16

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Viral Gastroenteritis Due to Rotavirus

Study ID

NCT01633190

Start date

Mar, 2012

Status verified date

Mar, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 16

Healthy Volunteers: Not accepted

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 Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

Rotavirus

- Children (0-16 years of age)admitted to hospital (through to December 31, 2020)

Primary outcome measure

  • - Changes in rotavirus hospitalization rates in 12 pediatric hospitals in Canada pre- and post rotavirus vaccine implementation within publicly funded provincial programs [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Melanie Laffin Thibodeau

(613) 526-9397melaniel@cps.ca

Locations

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

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Principal Investigator:

Manish Sadarangani, MD

Winnipeg Children's Hospital

Recruiting

Winnipeg, Manitoba, Canada, R3E 3P4

Principal Investigator:

Joanne Embree, MD

Janeway Children's Health and Rehabilitation Center

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Principal Investigator:

Cheryl Foo, MD

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K6R8

Principal Investigator:

Karina Top, MD

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Principal Investigator:

Nicole Le Saux, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Principal Investigator:

Shaun Morris, MD

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H3H 1P3

Principal Investigator:

Jesse Papenburg, 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

Principal Investigator:

Roseline Thibeault, MD

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Principal Investigator:

Ben Tan, MD

More Information

Sponsor

Canadian Paediatric Society

Last update posted

Mar 22, 2021

Last verified

Mar, 2021

Keywords

  • Surveillance
  • Rotavirus
  • Gastroenteritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Paediatric Society on 2021-03-22.