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

Gastro entérite Clinical Trial

— COSALE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862847
• Other study ID #: DE ROUGEMONT AOI 2014
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 10, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastro entérite

Intervention

Other:
• stool samples

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of viruses detected		Baseline	No