Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT04664556
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2020-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive Pneumococcal Disease Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1369}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of invasive pneumococcal disease', 'timeFrame': 'before hospital discharge', 'description': 'Number of severe cases according to age and pneumococcal serotypes distribution'}], 'secondaryOutcomes': [{'measure': 'Impact of vaccines', 'timeFrame': 'before hospital discharge', 'description': 'Number of invasive pneumococcal disease according to vaccine serotypes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infections', 'Pneumococcal Conjugate Vaccine', 'Antibiotic Treatment', 'Mortality']}, 'descriptionModule': {'briefSummary': 'After 7 then 13 valent pneumococcal conjugate vaccine implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with invasive pneumococcal disease for whom the pneumococcal strain is sent to the National reference Center for Pneumococci for serotyping', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolate of Streptococcus pneumoniae from at least one blood culture, or pleural fluid, or joint fluid, or cerebrospinal fluid or other normally sterile body site, or if there is a positive blood PCR.\n\nExclusion Criteria:\n\n* Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory'}, 'identificationModule': {'nctId': 'NCT04664556', 'briefTitle': 'Invasive Pneumococcal Disease Study', 'organization': {'class': 'OTHER', 'fullName': 'Association Clinique Thérapeutique Infantile du val de Marne'}, 'officialTitle': 'Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France', 'orgStudyIdInfo': {'id': 'IPD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort of invasive pneumococcal disease in children', 'interventionNames': ['Other: observational study']}], 'interventions': [{'name': 'observational study', 'type': 'OTHER', 'description': 'observational study', 'armGroupLabels': ['Cohort of invasive pneumococcal disease in children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', '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': 'ACTIV', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Levy Corinne', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '1 48 85 04 04', 'phoneExt': '+33'}, {'name': 'Bechet Stephane', 'role': 'CONTACT', 'email': 'stephane.bechet@activ-france.fr', 'phone': '1 48 85 96 68', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Levy Corinne', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Association Clinique Thérapeutique Infantile du val de Marne'}, {'name': 'Cohen Robert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Association Clinique Thérapeutique Infantile du val de Marne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}