Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT04209751
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2019-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PE-DIA
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A02341-56 | OTHER | ANSM | View |