Surveillance of Rotavirus Gastroenteritis

NCT02900703 | Unknown

• 1 other identifier: POTHIER Sanofi 2011
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• number of viral strains of rotavirus

  through the completion study an average 10 years

Study Arms (1)

PATIENT

Biological: stool samples

Interventions

stool samples BIOLOGICAL

PATIENT

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children presenting gastroenteritis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Pierre POTHIER

CONTACT

380295487; pierre.pothier@u-bourgogne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 14, 2016
• Study Start: February 1, 2007
• Primary Completion: February 1, 2017
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

FR (1)