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

Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea, Infantile
• Intervention / Treatment: Diagnostic test: Stool removal

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.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children aged from 0 to 16 years with diarrhea

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with summer diarrhea; Children aged 0 to 16 years with diarrhea	Diagnostic test: Stool removal; Stool removal; freezing an aliquot at -20 ° C and performing a direct examination. DNA extraction and serial PCR (Polymerase chain reaction).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe pathogens found in stool	Identification of pathogens by PCR and direct microscopic examination.	Day 0
Describe common factors that can serve as preventive tools for the transmission of these pathogens.	prospective analyzes of data collected from parental authority using a questionnaire	Day 0
Describe common factors that can be used as guidance on the etiology of diarrhea	prospective analyzes of the data collected from the parental authority and causal link with a specific germ	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Society ELITECH
• Investigators: Principal Investigator: Matthieu Verdan, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (ACTUAL): December 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: pediatric population; Microbiologic diagnosis; summer diarrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Emergencies; Diarrhea; Diarrhea, Infantile
• Other Study ID Numbers: RNI 2019 VERDAN; 2019-A02341-56 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No