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Surveillance of Rotavirus Gastroenteritis (Rotavirus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900703
Recruitment Status : Unknown
Verified September 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
  • 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

Condition or disease Intervention/treatment
Gastroenteritis Biological: stool samples

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Study Type : Observational
Estimated Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Surveillance of Rotavirus Gastroenteritis With a Perspective of Vaccination
Study Start Date : February 2007
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Group/Cohort Intervention/treatment
PATIENT Biological: stool samples



Primary Outcome Measures :
  1. number of viral strains of rotavirus [ Time Frame: through the completion study an average 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children presenting gastroenteritis
Criteria

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

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): NCT02900703


Contacts
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Contact: Pierre POTHIER 380295487 ext +33 pierre.pothier@u-bourgogne.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Pierre POTHIER    380295487 ext +33    pierre.pothier@u-bourgogne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02900703     History of Changes
Other Study ID Numbers: POTHIER Sanofi 2011
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases