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

Completed

• Conditions: Gastro entérite
• Interventions: Other: stool samples

• Registration Number: NCT02862847
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Study First Posted: 2016-08-11
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

• 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
• Children hospitalized or consulting at Dijon CHU during the 12 months of the study for any illness without diarrhoea (other than exclusion criteria).

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	stool samples	-
gastroenteritis	stool samples	-

Primary Outcome Measures

Name	Time	Method
Rate of viruses detected	Baseline

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France