- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02900703
Surveillance of Rotavirus Gastroenteritis (Rotavirus)
September 9, 2016 updated by: Centre Hospitalier Universitaire Dijon
Epidemiological Surveillance of Rotavirus Gastroenteritis With a Perspective of Vaccination
- Epidemiological studies have shown the diversity of resistance genotypes and the evolution of their prevalence in the paediatric population. This large study conducted in a context of very low vaccination coverage will generate more precise data on the natural epidemiological evolution of rotavirus, notably the G9 genotype, which has appeared relatively recently.
- This study will allow us to identify and document rare or unusual strains of human or animal origin. The complete genetic characterization of these strains will also make it possible to study their ability to recombine and to assess the risk of emergence. Among these still rare strains, the investigators are particularly monitoring G12 rotavirus, whose ability to recombine raises the risk of emergence.
- For at least one of the centres taking part in the study, the paediatric population studied will be given strong vaccination coverage. It will be extremely interesting to compare the results obtained in the vaccinated population with non-vaccinated children to assess the impact of this vaccination on the distribution of rotavirus genotypes
Study Overview
Study Type
Observational
Enrollment (Anticipated)
9000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pierre POTHIER
- Phone Number: +33 380295487
- Email: pierre.pothier@u-bourgogne.fr
Study Locations
-
-
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Dijon, France, 21079
- Recruiting
- Chu Dijon Bourgogne
-
Contact:
- Pierre POTHIER
- Phone Number: +33 380295487
- Email: pierre.pothier@u-bourgogne.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children presenting gastroenteritis
Description
Inclusion Criteria:
- Children hospitalized or consulting in one of the participating centres since January 2007 for acute gastroenteritis (AGE). AGE is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or one of the following signs - diarrhoea or vomiting accompanied by at least 2 additional symptoms among diarrhoea or vomistin, abdominal pain, fever.
Exclusion Criteria:
- Children older than 5 years.
- Children presenting chronic diarrhoea (> 2 weeks).
- Children presentant immune deficiency.
- Children presenting nosocomial gastroenteritis. The nosocomial nature will be determined by the onset of acute diarrhoea occuring after 48 hours following admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PATIENT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of viral strains of rotavirus
Time Frame: through the completion study an average 10 years
|
through the completion study an average 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Anticipated)
February 1, 2017
Study Registration Dates
First Submitted
September 5, 2016
First Submitted That Met QC Criteria
September 9, 2016
First Posted (Estimate)
September 14, 2016
Study Record Updates
Last Update Posted (Estimate)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 9, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POTHIER Sanofi 2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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