MedDataX Logo

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

NCT ID: NCT04209751

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diarrhea, Infantile

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Microbiologic diagnosis summer diarrhea pediatric population

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children with summer diarrhea

Children aged 0 to 16 years with diarrhea

Stool removal

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stool removal

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Society ELITECH

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthieu Verdan

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A02341-56

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2019 VERDAN

Identifier Type: -

Identifier Source: org_study_id