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

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.

Study Overview

• Status: Completed
• Conditions: Gastro entérite
• Intervention / Treatment: Other: stool samples

• Study Type: Observational
• Enrollment (Actual): 615

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control	Other: stool samples
gastroenteritis	Other: stool samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of viruses detected	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (ESTIMATE): August 11, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: DE ROUGEMONT AOI 2014