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CompletedNCT02862847COSALEUpdated Aug 11, 2016

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

An observational study in Gastro entérite, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged Up to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-11.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
615
Ages
Up to 5 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Gastro entérite

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03

In context

Infections

6,686 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 615 is above the median of 240 across 2,136 observational studies indexed under Infections.

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Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
615 participants (actual)
Patient registry
No

Groups and cohorts

  • gastroenteritis

    Other: stool samples

  • control

    Other: stool samples

Interventions

  • Otherstool samples
06

What researchers measure

Primary outcomes

  1. Rate of viruses detected

    Time frame: Baseline

07

Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02862847
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Jul 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Aug 11, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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