Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)

NCT04209751 | Completed

• 2 other identifiers: RNI 2019 VERDAN2019-A02341-56
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Acute diarrhea in children is a public health problem. It is estimated that children under 3 years are subject to 1 or 2 episodes of diarrhea per year in Europe. These diarrheal episodes are frequent, expensive and responsible for many consultations and hospitalizations in developed countries. The origin of diarrhea in children is viral in about 70% of cases. The diagnosis of a viral infection is often considered without microbiological evidence. However, microbiological evidence is recommended for certain categories of patients. The involvement of bacteria or parasites in the child's diarrhea does not seem negligible. The main objective of this study is to estimate the prevalence of infectious diarrhea among summer diarrhea in children leading to pediatric emergency room visits. Secondarily, we will describe the pathogens responsible for childhood diarrhea during the summer period, describe common factors that can serve as guidance on the etiology of diarrhea, and describe common factors that can be used as tools. preventive to the transmission of these pathogens.

Conditions

Diarrhea, Infantile

Keywords

Microbiologic diagnosis; summer diarrhea; pediatric population

Outcome Measures

Primary Outcomes (1)

• Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visits

  percentage of positive stool tests (PCR (polymerase chain reaction) and direct microscopic examination)Stool sent instantly to the laboratory. Microbological research : PCR and direct microscopic examination.

  Day 0

Secondary Outcomes (3)

• Describe pathogens found in stool

  Day 0

• Describe common factors that can serve as preventive tools for the transmission of these pathogens.

  Day 0

• Describe common factors that can be used as guidance on the etiology of diarrhea

  Day 0

Study Arms (1)

Children with summer diarrhea

Children aged 0 to 16 years with diarrhea

Diagnostic Test: Stool removal

Interventions

Stool removal DIAGNOSTIC_TEST

Stool removal; freezing an aliquot at -20 ° C and performing a direct examination. DNA extraction and serial PCR (Polymerase chain reaction).

Children with summer diarrhea

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged from 0 to 16 years with diarrhea

You may qualify if:

• Children aged from 0 to 16 years with diarrhea
• pediatric emergency at the University Hospital of Clermont-Ferrand consultation
• between june and september 2020

You may not qualify if:

• consent not felt by the child or the person with parental authority
• no stool removal

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Society ELITECH: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Diarrhea, Infantile

Condition Hierarchy (Ancestors)

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthieu Verdan

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 24, 2019
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-09

Locations

FR (1)