Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
Study NCT ID:
NCT04685850
Status:
TERMINATED
Last Update Posted:
2025-06-13
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}], 'ancestors': [{'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'lack of inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of children with at least one neurological, orthopedic or sensory sequelae', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Number of children with severe neurological sequelae', 'timeFrame': '1 year'}, {'measure': 'Number of children with orthopedic complications', 'timeFrame': '1 year'}, {'measure': 'Number of children with sensory disorders', 'timeFrame': '1 year'}, {'measure': 'Number of children with skin sequelae', 'timeFrame': '1 year'}, {'measure': 'Number of children with learning disabilities', 'timeFrame': '1 year'}, {'measure': 'Number of children with cognitive or psychological difficulties identified on the WPPSI, WISC V or VINELAND depending on their age and capacity', 'timeFrame': '1 year', 'description': '95% of the population has a Total IQ between 70 and 130 (from low intelligence to high intelligence).'}, {'measure': 'Number of consultations during follow-up', 'timeFrame': '1 year'}, {'measure': 'Post-traumatic stress in parents using the IES-R questionnaire', 'timeFrame': '1 year', 'description': 'A score up to 33 is associated with a stress post traumatic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningitis, Meningococcal', 'Sequela']}, 'referencesModule': {'references': [{'pmid': '35617288', 'type': 'DERIVED', 'citation': 'Baloche A, Jung C, Levy M, Elbez-Rubinstein A, Bechet S, Layouni I, Monguillot G, Taha MK, Cohen R, Levy C. Long-term impact of invasive meningococcal disease in children: SEINE study protocol. PLoS One. 2022 May 26;17(5):e0268536. doi: 10.1371/journal.pone.0268536. eCollection 2022.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/35617288/', 'label': 'Long-term impact of invasive meningococcal disease in children: SEINE study protocol'}]}, 'descriptionModule': {'briefSummary': "While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.\n\nThe objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from 0 to 17 years old who had meningococcal meningitis between 2010 and 2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants and children from 0 to 17 years old\n* Having had meningitis or meningococcal purpura fulminans between 2010 and 2021\n* Delay ≥ 1 year between the date of diagnosis of meningitis or purpura meningococcal fulminans and the date of inclusion in the study (signature of the informed consent)\n* The holders of parental authority have read and understood the information letter and their express consent has been obtained\n* Patient affiliated to a social security system (Social Security or Universal Medical Coverage)\n\nExclusion Criteria:\n\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT04685850', 'acronym': 'SEINE', 'briefTitle': 'Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach', 'orgStudyIdInfo': {'id': 'SEINE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sequela evaluation', 'type': 'OTHER', 'description': "clinical and neurological examination, psychological evaluation (cognitive performance), an auditory, speech and visual assessment and an evaluation of the child's school performance"}]}, 'contactsLocationsModule': {'locations': [{'zip': '94720', 'city': 'Le Kremlin-Bicêtre', 'state': 'Kremlin Bicêtre', 'country': 'France', 'facility': 'CHU Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '74370', 'city': 'Annecy', 'country': 'France', 'facility': 'CHU Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'CHI créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '91560', 'city': 'Crosne', 'country': 'France', 'facility': 'Centre Intercommunal de Villeneuve Saint Georges', 'geoPoint': {'lat': 48.71921, 'lon': 2.45728}}, {'zip': '91345', 'city': 'Longjumeau', 'country': 'France', 'facility': 'Groupe Hospitalier Nord Essonne', 'geoPoint': {'lat': 48.69307, 'lon': 2.29431}}, {'zip': '77100', 'city': 'Meaux', 'country': 'France', 'facility': 'GHEF site de Meaux', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Robert debré hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'Ch Pontoise', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}