Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT04471493
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric and Ambulatory Research in Infectious Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D002644', 'term': 'Chickenpox'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2030-08-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the number of infectious diseases', 'timeFrame': '5 years', 'description': 'proportion of children under 16 years, with infectious disease'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the use of point of care tests', 'timeFrame': '5 years', 'description': 'Proportion of use of point of care tests and positivity rate according to the infectious diseases'}, {'measure': 'Evaluation of the antibiotic treatments', 'timeFrame': '5 years', 'description': 'Proportion of each antibiotic treatments according to the infectious diseases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccination', 'Antibiotic treatment', 'Point of care test', 'automated data extraction', 'network'], 'conditions': ['Otitis', 'Bronchiolitis', 'Influenza', 'Pharyngitis', 'Varicella', 'Pneumonia', 'Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '33657594', 'type': 'DERIVED', 'citation': 'Cohen R, Bechet S, Gelbert N, Frandji B, Vie Le Sage F, Thiebault G, Kochert F, Cahn-Sellem F, Werner A, Ouldali N, Levy C. New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era. Pediatr Infect Dis J. 2021 Jul 1;40(7):674-680. doi: 10.1097/INF.0000000000003116.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33657594/', 'label': 'New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/36034052/', 'label': 'Trends in pediatric ambulatory community acquired infections before and during COVID-19 pandemic: A prospective multicentric surveillance study in France'}]}, 'descriptionModule': {'briefSummary': 'Many ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.', 'detailedDescription': '107 pediatricians among the 1400 members of the French ambulatory pediatric association, AFPA (Association Française de Pédiatrie Ambulatoire) were involved in this survey.To belong to the PARI network, pediatricians have to use the same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France) for electronic medical record of children. The pediatricians were trained to the use of point of care tests and to the infectious diagnoses (otitis, pharyngitis, varicella, bronchiolitis, influenza, pneumonia, etc..). The study population consisted of all children under 16 years of age from the patient population for which an infectious disease was diagnosed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children under 16 years with infectious disease', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children under 16 years of age with at least one infectious disease among:\n* pharyngitis\n* otitis\n* pneumonia\n* influenza\n* bronchiolitisz\n* varicella\n* gastroenteritis\n* enterovirus disease\n* bordetella pertussis disease\n* using the same same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France)\n\nExclusion Criteria:\n\n* parental refusal'}, 'identificationModule': {'nctId': 'NCT04471493', 'acronym': 'PARI', 'briefTitle': 'Pediatric and Ambulatory Research in Infectious Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Association Clinique Thérapeutique Infantile du val de Marne'}, 'officialTitle': 'Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study', 'orgStudyIdInfo': {'id': 'ACT0116'}}, 'contactsLocationsModule': {'locations': [{'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corinne Levy, MD', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '0033148850404'}, {'name': 'Stéphane Béchet, MSc', 'role': 'CONTACT', 'email': 'stephane.bechet@activ-france.fr', 'phone': '0033148850404'}], 'facility': 'AFPA', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Corinne LEVY, MD', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '0033148850404'}, {'name': 'Stéphane Béchet, MSc', 'role': 'CONTACT', 'email': 'stephane.bechet@activ-france.fr', 'phone': '0033148850404'}], 'overallOfficials': [{'name': 'Robert Cohen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Association Clinique et Thérapeutique Infantile du Val de Marne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, 'collaborators': [{'name': 'AFPA (Association Française de Pédiatrie Ambulatoire)', 'class': 'UNKNOWN'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}