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OpenTrials
Completed

NCT Number: NCT02862847

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

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.

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Key information

Conditions

Gastro entérite

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool samples

Other

Primary outcomes

  1. Rate of viruses detected

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: COSALE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2016
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.