Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04664569
Status:
RECRUITING
Last Update Posted:
2022-12-27
First Post:
2020-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Bacterial Meningitis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 8230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2001-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-22', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'before the hospital discharge', 'description': 'Number of death according to age and bacteria'}], 'secondaryOutcomes': [{'measure': 'treatment failures', 'timeFrame': '48 hours after the antibiotic treatment and new lumbar puncture', 'description': 'Number of antibiotic treatment failures according to bacteria after the control of lumbar puncture'}, {'measure': 'impact of vaccines', 'timeFrame': 'before the hospital discharge', 'description': 'Number of vaccination failures according to age, number of doses and bacteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningitis', 'Children, Only', 'Pneumococcal Conjugate Vaccine', 'Meningococcal Vaccines', 'H. Influenzae Vaccine', 'Neonatal Infection', 'Antibiotic Treatment', 'Case Fatality Rate']}, 'referencesModule': {'references': [{'pmid': '40924727', 'type': 'DERIVED', 'citation': 'Maunier L, Levy C, Baron A, Weill FX, Bechet S, Pardos de la Gandara M, Caseris M, Abdoul C, Dommergues MA, Cohen R, Bonacorsi S. Retrospective Description of 27 Cases of Nontyphoidal Salmonella Meningitis in Pediatrics Over 22 Years in France Pleads for a Revision of Age Limit for the Treatment of Salmonella Gastroenteritis in Children. Pediatr Infect Dis J. 2026 Jan 1;45(1):e10-e12. doi: 10.1097/INF.0000000000004966. Epub 2025 Sep 3.'}, {'pmid': '40063777', 'type': 'DERIVED', 'citation': 'Fafi I, Cohen R, Levy C, Varon E, Amor-Chelihi L, Benhaim P, Houlier M, Koehl B, De Montalembert M, Allali S, Gauthier A, Odievre MH, Gajdos V, Escoda S, Kamdem A, Costa G, Guillaumat C, Thuret I, Ouldali N, Gaschignard J, Carbonnelle E, De Pontual L, Pham LL. High Mortality Due to Pneumococcal Meningitis in Children With Sickle Cell Disease: A French Multicenter Observational Study From 2001 to 2021. Pediatr Infect Dis J. 2025 Jun 1;44(6):496-502. doi: 10.1097/INF.0000000000004755. Epub 2025 Mar 7.'}, {'pmid': '38108805', 'type': 'DERIVED', 'citation': 'Rybak A, Ouldali N, Varon E, Taha MK, Bonacorsi S, Bechet S, Angoulvant F, Cohen R, Levy C; French Pediatric Meningitis Network. Vaccine-preventable Pediatric Acute Bacterial Meningitis in France: A Time Series Analysis of a 19-Year Prospective National Surveillance Network. Pediatr Infect Dis J. 2024 Jan 1;43(1):74-83. doi: 10.1097/INF.0000000000004134. Epub 2023 Nov 13.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31220046/', 'label': 'Recurrent Pneumococcal Meningitis in Children: A Multicenter Case-control Study'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30049623/', 'label': 'Incidence of paediatric pneumococcal meningitis and emergence of new serotypes: a time-series analysis of a 16-year French national survey'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29045606/', 'label': 'Clinical and Laboratory Features of Group B Streptococcus Meningitis in Infants and Newborns: Study of 848 Cases in France, 2001-2014'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/28403047/', 'label': 'Risk Factors in Children Older Than 5 Years With Pneumococcal Meningitis: Data From a National Network'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27753774/', 'label': 'Neonatal Meningococcal Meningitis In France From 2001 To 2013'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27595445/', 'label': 'Comparative impact of pneumococcal conjugate vaccines on pneumococcal meningitis according to underlying conditions'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27020729/', 'label': 'Outcomes of bacterial meningitis in children'}]}, 'descriptionModule': {'briefSummary': 'Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children 0 day to 18 years with bacterial meningitis or purpura fulminans', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and/or positive CSF polymerase chain reaction (PCR), and/or positive blood culture with CSF pleocytosis (\\> 10 cells/µL).\n* purpura fulminans\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04664569', 'briefTitle': 'National Bacterial Meningitis Study', 'organization': {'class': 'OTHER', 'fullName': 'Association Clinique Thérapeutique Infantile du val de Marne'}, 'officialTitle': 'National Observatory of Bacterial Meningitis in Children and Newborns', 'orgStudyIdInfo': {'id': 'Obs meningitis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort of bacterial meningitis in children', 'interventionNames': ['Other: observational study']}], 'interventions': [{'name': 'observational study', 'type': 'OTHER', 'description': 'observational study', 'armGroupLabels': ['Cohort of bacterial meningitis in children']}]}, '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': 'ACTIV', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Corinne Levy, MD', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '0033148850404'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}