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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Gastro entérite

Treatments

Other: stool samples

Study type

Observational

Funder types

Other

Identifiers

NCT02862847
DE ROUGEMONT AOI 2014

Details and patient eligibility

About

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.

Enrollment

615 patients

Sex

All

Ages

Under 5 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

615 participants in 2 patient groups

gastroenteritis
Treatment:
Other: stool samples
control
Treatment:
Other: stool samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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