Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants

NCT02862847 | Completed

• 1 other identifier: DE ROUGEMONT AOI 2014
• Study Type: observational
• Target: 615
• Locations: 1 country
• Sites: 1

Brief Summary

Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied. To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea. The aim of this study is thus to:

• show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature.
• confirm the relationship between the diarrhoea and the infection with these viruses.

Conditions

Gastro entérite

Outcome Measures

Primary Outcomes (1)

• Rate of viruses detected

  Baseline

Study Arms (2)

gastroenteritis

Other: stool samples

control

Other: stool samples

Interventions

stool samples OTHER

control; gastroenteritis

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children de moins de 5ans présentant ou non un épisode de gasto entérite

You may qualify if:

• Children younger than 5 years
• Children hospitalized or consulting at Dijon CHU during the 12 months of the study for acute gastroenteritis. Acute gastroenteritis is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or signs (diarrhoea or vomiting) accompanied by at least 2 additional symptoms among diarrhoea or vomiting, abdominal pain, fever
• for controls
• Children younger than 5 years old

You may not qualify if:

• Persons without national health insurance cover
• Children older than 5 years.
• Children presenting chronic diarrhoea (\> 2 weeks) (e.g. Crohn and UC)
• Children with immune deficiency.
• Children with nosocomial gastroenteritis; the nosocomial aspect will be defined as the onset of acute diarrhoea occurring after the 48th hour after admission
• for controls
• Persons without national health insurance cover
• Children older than 5 years.
• Children with chronic diarrhoea (\> 2 weeks) (e.g. Crohn and UC)
• Children with immune deficiency.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Study Design

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

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 11, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-07

Locations

FR (1)