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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209751
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Collaborator:
Society ELITECH
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment
Diarrhea, Infantile 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Describe pathogens found in stool [ Time Frame: Day 0 ]
    Identification of pathogens by PCR and direct microscopic examination.

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged from 0 to 16 years with diarrhea
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209751


Contacts
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Contact: Lise Laclautre +334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Contact: Matthieu Verdan       mverdan@chu-clermontferrand.fr   
Principal Investigator: Matthieu Verdan         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Society ELITECH
Investigators
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Principal Investigator: Matthieu Verdan University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04209751    
Other Study ID Numbers: RNI 2019 VERDAN
2019-A02341-56 ( Other Identifier: ANSM )
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Microbiologic diagnosis
summer diarrhea
pediatric population
Additional relevant MeSH terms:
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Emergencies
Diarrhea
Diarrhea, Infantile
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms