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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04209751
Acronym
PE-DIA
Enrollment
95
Registered
2019-12-24
Start date
2020-06-01
Completion date
2020-09-30
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Infantile

Keywords

Microbiologic diagnosis, summer diarrhea, pediatric population

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.

Interventions

DIAGNOSTIC_TESTStool removal

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER
Society ELITECH
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visitsDay 0percentage 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.

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMatthieu Verdan

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026