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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

Tracking Information
First Submitted Date September 5, 2016
First Posted Date September 14, 2016
Last Update Posted Date September 14, 2016
Study Start Date February 2007
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2016)
number of viral strains of rotavirus [ Time Frame: through the completion study an average 10 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surveillance of Rotavirus Gastroenteritis
Official Title Epidemiological Surveillance of Rotavirus Gastroenteritis With a Perspective of Vaccination
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children presenting gastroenteritis
Condition Gastroenteritis
Intervention Biological: stool samples
Study Groups/Cohorts PATIENT
Intervention: Biological: stool samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 9, 2016)
9000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 5 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02900703
Other Study ID Numbers POTHIER Sanofi 2011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date September 2016