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

NCT ID: NCT02862847

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 615 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-07-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

gastroenteritis

stool samples

Intervention Type: OTHER

control

stool samples

Intervention Type: OTHER

Interventions

stool samples

Intervention Type: OTHER

Eligibility Criteria

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

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.

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

DE ROUGEMONT AOI 2014

Identifier Type: -

Identifier Source: org_study_id