Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01485705
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2011-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057126', 'term': 'Nuclear Receptor Subfamily 4, Group A, Member 2'}], 'ancestors': [{'id': 'D057093', 'term': 'Orphan Nuclear Receptors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018160', 'term': 'Receptors, Cytoplasmic and Nuclear'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2011-09-06', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of optimal care and of non optimal care in the initial care (before arrival at the intensive care unit) of children (from West France regions) suffering of severe bacterial infections.', 'timeFrame': '1day', 'description': 'For each child medical file, the verdict "optimal care" or the verdict " non optimal care" will be determined by two independent experts, blinded from each other. If verdict base their judgement through recommendations listed in the literature.'}], 'secondaryOutcomes': [{'measure': 'characteristics of sub-optimal cares', 'timeFrame': '1 day', 'description': 'Experts will explain their verdict by answering to a list of questions. These questions will allow to identify and classify characteristics of defaults of cares .'}, {'measure': 'determinants of sub-optimal cares', 'timeFrame': '1 day', 'description': 'To identify determinants of sub-optimal cares (examples : place of medical care, qualification and experience of the Medical Doctor, moment of medical care.'}, {'measure': 'consequences of initial sub-optimal cares', 'timeFrame': '1 day', 'description': 'To identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe bacterial infection'], 'conditions': ['Bacterial Infection']}, 'referencesModule': {'references': [{'pmid': '37260312', 'type': 'DERIVED', 'citation': 'Malorey D, Lorton F, Chalumeau M, Bourgoin P, Boussicault G, Chantreuil J, Gaillot T, Roue JM, Martinot A, Assathiany R, Saulnier JP, Caillon J, Grain A, Gras-Le Guen C, Launay E. Distribution, Consequences, and Determinants of Time to Antibiotics in Children With Community-Onset Severe Bacterial Infection: A Secondary Analysis of a Prospective Population-Based Study. Pediatr Crit Care Med. 2023 Sep 1;24(9):e441-e451. doi: 10.1097/PCC.0000000000003306. Epub 2023 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the frequency of sub-optimal care in the initial care (before arrival at the intensive care unit) of children from "West France regions" suffering of severe bacterial infections.The characteristic "optimal or not" of the initial medical care will be determined by 2 independent experts, blinded from each other and blinded from the issue of the care. In case of a discordance between the two experts, a third expert will be demanded. Three possibilities of conclusion will be proposed to the experts: "sure sub-optimal medical care", "possible suboptimal care" and "optimal care".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child from West France regions\n* Aged between 1 month and 16 years old,\n* Admitted at the intensive care unit for a severe bacterial infection and with the first symptoms appeared when child was at home or hospitalized since less than 48h\n* Children dead at home will also be included in this study via the mobil medical urgency help unit (french term : "SAMU")\n\nExclusion Criteria:\n\n* Patient not fulfilling inclusion criteria\n* Child with a nosocomial infection\n* Child dead or admitted at the intensive care unit following a pertussis- Child not admitted at the intensive care or not dead at home in a context of infection.\n* Child with viral or fungic infection admitted at the intensive care unit.'}, 'identificationModule': {'nctId': 'NCT01485705', 'acronym': 'Diabact', 'briefTitle': 'Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Frequency, Consequences and Determinants of Sub-optimal Care in the Initial Care of Severe Bacterial Infections of the Child', 'orgStudyIdInfo': {'id': 'BRD/08/06-T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Retrospective examination by experts whether care given fo child admitted at the ICU for suspicion of bacterial infection (not nosocomial) was optimal or not', 'type': 'OTHER', 'description': 'When child is admitted at Intensive Care Unit (ICU) for suspicion of bacterial infection that is not nosocomial, data on child\'s infection and cares received, is completed on an electronic Case Report Form (e-CRF) by Doctor of ICU. Characteristic "optimal or not" of initial medical care is then determined by the independent experts blinded from issue of the care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}