Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT05788861
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive Group A Streptococcal Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalisation', 'timeFrame': '1 year', 'description': 'How long patient was hospitalised during this infection'}, {'measure': 'Treatments provided in intensive care unit', 'timeFrame': '1 year', 'description': 'what treatments are used in intensive care unit to treat infection'}, {'measure': 'Complications', 'timeFrame': '1 year', 'description': 'what are the complications due to severe infection'}, {'measure': 'Treatments used in routine care unit', 'timeFrame': '1 year', 'description': 'which treatments are used in routine care unit to treat the infection'}, {'measure': 'Risk factors', 'timeFrame': '1 year', 'description': 'description of underlying conditions'}, {'measure': 'Characterization of Group A Streptococcus strains', 'timeFrame': '1 year', 'description': 'Characterization of Group A Streptococcus strains by the CNR'}, {'measure': 'Death', 'timeFrame': '1 year', 'description': 'Death Outcome during hospitalisation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis Due to Streptococcus, Group A', 'Risk Factors', 'Severe Infection', 'Medical Care', 'Medical Complications', 'Outcome, Fatal', 'Therapy', 'Strain', 'Virulence Factors']}, 'descriptionModule': {'briefSummary': 'This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection', 'detailedDescription': 'The main of this study is to identify and record cases of invasive and severe infections due to Streptococcus pyogenes. In order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management.\n\nAdmitted patients to intensive care or critical care units in reported via Santé Publique France may also be included in this study.\n\nSecondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group A Streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatrics patients with documented invasive infection due to Group A Streptococcus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\<18 years\n* Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis)\n\nExclusion Criteria:\n\n* Opposition of the patient or his/her legal representative'}, 'identificationModule': {'nctId': 'NCT05788861', 'acronym': 'ISAI', 'briefTitle': 'Invasive Group A Streptococcal Infection', 'organization': {'class': 'OTHER', 'fullName': 'Association Clinique Thérapeutique Infantile du val de Marne'}, 'officialTitle': 'French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)', 'orgStudyIdInfo': {'id': 'ISAI'}}, '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': 'Yves Gillet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'hôpital Femme-Mère-Enfant, Bron'}, {'name': 'Camille Brehin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOPITAUX MERE et ENFANTS CHU TOULOUSE'}, {'name': 'Lionel Berthomieu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'Corinne Levy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Association Clinique Thérapeutique Infantile du val de Marne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}