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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003968', 'term': 'Diarrhea, Infantile'}], 'ancestors': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-13', 'studyFirstSubmitDate': '2019-11-28', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visits', 'timeFrame': 'Day 0', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Describe pathogens found in stool', 'timeFrame': 'Day 0', 'description': 'Identification of pathogens by PCR and direct microscopic examination.'}, {'measure': 'Describe common factors that can serve as preventive tools for the transmission of these pathogens.', 'timeFrame': 'Day 0', 'description': 'prospective analyzes of data collected from parental authority using a questionnaire'}, {'measure': 'Describe common factors that can be used as guidance on the etiology of diarrhea', 'timeFrame': 'Day 0', 'description': 'prospective analyzes of the data collected from the parental authority and causal link with a specific germ'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiologic diagnosis', 'summer diarrhea', 'pediatric population'], 'conditions': ['Diarrhea, Infantile']}, 'descriptionModule': {'briefSummary': "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.\n\nThe involvement of bacteria or parasites in the child's diarrhea does not seem negligible.\n\nThe main objective of this study is to estimate the prevalence of infectious diarrhea among summer diarrhea in children leading to pediatric emergency room visits.\n\nSecondarily, 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.", 'detailedDescription': '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.\n\nIf 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).\n\nThe doctor in charge of the patient will complete a pre-established clinical information sheet.\n\nIn 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.\n\nTherapeutic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged from 0 to 16 years with diarrhea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged from 0 to 16 years with diarrhea\n* pediatric emergency at the University Hospital of Clermont-Ferrand consultation\n* between june and september 2020\n\nExclusion Criteria:\n\n* consent not felt by the child or the person with parental authority\n* no stool removal'}, 'identificationModule': {'nctId': 'NCT04209751', 'acronym': 'PE-DIA', 'briefTitle': 'Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits', 'orgStudyIdInfo': {'id': 'RNI 2019 VERDAN'}, 'secondaryIdInfos': [{'id': '2019-A02341-56', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with summer diarrhea', 'description': 'Children aged 0 to 16 years with diarrhea', 'interventionNames': ['Diagnostic Test: Stool removal']}], 'interventions': [{'name': 'Stool removal', 'type': 'DIAGNOSTIC_TEST', 'description': 'Stool removal; freezing an aliquot at -20 ° C and performing a direct examination. DNA extraction and serial PCR (Polymerase chain reaction).', 'armGroupLabels': ['Children with summer diarrhea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Matthieu Verdan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society ELITECH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}