Clinical trial NCT04209751: Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)
Official title: Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea, Infantile
Keywords: Microbiologic diagnosis
summer diarrhea
pediatric population
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Society ELITECH
First posted: 2019-12-24
Enrollment: 95
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged from 0 to 16 years with diarrhea

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.

Detailed description: After obtaining consent from the holders of parental authority, a stool collection will be requested from all pediatric emergency patients presenting as a reason for "diarrhea" consultations between June 1 and September 30, 2020. It will be given by the nurse organizing the reception, a medical information questionnaire and a stool collection container for those accompanying a child with diarrhea.

If the child presents stool during the waiting period or during the medical consultation, these will be collected and sent to the medical biology laboratory of the University Hospital for a broad analysis (virological, bacteriological and parasitological).

The doctor in charge of the patient will complete a pre-established clinical information sheet.

In the laboratory, the stool will be taken care of and a DNA extract will be made and preserved. The search for pathogens will be carried out by molecular biology, by series, non-prospectively. The results will only be transmitted at a distance and will not be communicated to families.

Therapeutic management of children included in the study will be identical to the usual practice. Microbiological analysis will not delay, prolong or disrupt the treatment of the acute episod of diarrhea.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visits
timeFrame: Day 0
Secondary outcomes:
measure: Describe pathogens found in stool
timeFrame: Day 0
measure: Describe common factors that can serve as preventive tools for the transmission of these pathogens.
timeFrame: Day 0
measure: Describe common factors that can be used as guidance on the etiology of diarrhea
timeFrame: Day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Matthieu Verdan
role: PRINCIPAL_INVESTIGATOR
References: