Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04209751 |
| Other study ID # |
RNI 2019 VERDAN |
| Secondary ID |
2019-A02341-56 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
September 30, 2020 |
Study information
| Verified date |
September 2020 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
