Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA) (PE-DIA)
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|ClinicalTrials.gov Identifier: NCT04209751|
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
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.
|Condition or disease||Intervention/treatment|
|Diarrhea, Infantile||Diagnostic Test: Stool removal|
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|
|Estimated Enrollment :||150 participants|
|Official Title:||Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||November 2020|
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).
- Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visits [ Time Frame: Day 0 ]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.
- Describe pathogens found in stool [ Time Frame: Day 0 ]Identification of pathogens by PCR and direct microscopic examination.
- Describe common factors that can serve as preventive tools for the transmission of these pathogens. [ Time Frame: Day 0 ]prospective analyzes of data collected from parental authority using a questionnaire
- Describe common factors that can be used as guidance on the etiology of diarrhea [ Time Frame: Day 0 ]prospective analyzes of the data collected from the parental authority and causal link with a specific germ
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209751
|Contact: Lise Laclautrefirstname.lastname@example.org|
|CHU de Clermont-Ferrand|
|Clermont-Ferrand, France, 63000|
|Contact: Matthieu Verdan email@example.com|
|Principal Investigator: Matthieu Verdan|
|Principal Investigator:||Matthieu Verdan||University Hospital, Clermont-Ferrand|