Viral Gastroenteritis Due to RotavirusNCT01633190
Canadian Rotavirus Surveillance Through the Immunization Monitoring Program Active (IMPACT)
An observational study of Viral Gastroenteritis Due to Rotavirus, run by Canadian Paediatric Society at 12 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 16 years
- Conditions the study is for
- Viral Gastroenteritis Due to Rotavirus
- How many people
- 2,500 participants
- Where
- 12 sitesCanada
- Study dates
- Mar 2012to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children age 0-16 admitted to the participating IMPACT hospitals (to December 31, 2020) with confirmation of positive stool samples.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites, 12 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Taj Jadavji, MD
- Recruiting
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9
Wendy Vaudry, MD
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K6R8
Karina Top, MD
Karina Top, MD
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Jesse Papenburg, MD
- Recruiting
CHU Sainte-Justine Hospital
Montreal, Quebec, H3T 1C5
Marc Lebel, MD
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Nicole Le Saux, MD
Nicole Le Saux, MD
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Ben Tan, MD
- Recruiting
Janeway Children's Health and Rehabilitation Center
St. John's, Newfoundland and Labrador, A1B 3V6
Cheryl Foo, MD
- Recruiting
Centre Mère-Enfant de Québec -Pavillon CHUL
Ste Foy, Quebec, G1V 4G2
Roseline Thibeault, MD
Roseline Thibeault, MD
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Shaun Morris, MD
Shaun Morris, MD
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
Manish Sadarangani
Manish Sadarangani, MD
- Recruiting
Winnipeg Children's Hospital
Winnipeg, Manitoba, R3E 3P4
Joanne Embree, MD
Joanne Embree, MD
About this study
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
- 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.
Read the 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.
- Conditions
- Viral Gastroenteritis Due to Rotavirus
- Keywords
- Surveillance, Rotavirus, Gastroenteritis
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rotavirus | - Children (0-16 years of age)admitted to hospital (through to December 31, 2020) |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
Measured: 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 outcomes (2)
- The number of hospital acquired rotavirus infections in children compared pre- and post immunization burden across the network.
Described in the title
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startMar 2012
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Gastroenteritis Due to RotavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Paediatric Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Le Saux, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633190
- Sponsor's protocol ID
- ROTA 2010-2017
- Status last verified
- Mar 2021
- First submitted
- 12 Jun 2012
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01633190
- Acronym / sponsor ID
- ROTA 2010-2017
- Conditions
- Viral Gastroenteritis Due to Rotavirus
- Keywords
- Surveillance, Rotavirus, Gastroenteritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Canadian Paediatric SocietyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotavirus | – | –- Children (0-16 years of age)admitted to hospital (through to December 31, 2020) |
Who may qualify
- Ages
- 1 minute to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children age 0-16 admitted to the participating IMPACT hospitals (to December 31, 2020) with confirmation of positive stool samples.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- 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
Described In the title
2 secondary outcomes
- 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, 2020.
- The most common rotavirus genotypes in hospitalized patients
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- IMPACT general web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Le Saux, MD principal investigator
Children's Hospital of Eastern Ontario
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Gastroenteritis Due to Rotavirus, run by Canadian Paediatric Society at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Le Saux, MD (613-737-7600 ext. 2651, lesaux@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.