Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:57 AM
Study NCT ID:
NCT04005560
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.', 'timeFrame': '6 months', 'description': 'The Pediatric Quality of Life inventory questionnaire has various versions depending on the patient age, from 5 years old to adult age. Patients will answers many questions in the academic, emotional, physical and social fields. It exists the same questionnaire adapted for parents. At the end, there is a score for each field and a total score.'}], 'secondaryOutcomes': [{'measure': 'Identify quality of life determinants.', 'timeFrame': '6 months', 'description': 'DIABACT III database has factors that could affect quality of life.'}, {'measure': 'Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.', 'timeFrame': '6 months', 'description': 'During the telephone interview, we will ask many questions about organs disorders and psychological disorders (Strenghts and Difficulties Questionnaire), specialized medical follow-up, medication, need physical or material assistance, financial and psychological family impact'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe bacterial infection', 'quality of life', 'long term sequela', 'pediatric intensive care unit', 'children'], 'conditions': ['Quality of Life', 'Sequela']}, 'descriptionModule': {'briefSummary': "The aim of this study is to assess patient's quality of life 5 to 10 years after a severe bacterial infection with hospitalization in a intensive unit care. The population is derived from the DIABACT III study. The investigators will include every patient still alive. To evaluate our question, patients and their parents will answer quality of life questionnaires. The investigators will also have telephone interviews with the parents to know somatic and psychological effects on their child.\n\nThe investigators will see if quality of life and sequelae differ depending on various studied factors.", 'detailedDescription': "The aim of this study is to assess patient's quality of life 5 to 10 years after hospitalization in intensive car unit for a severe bacterial infection. The population is derived from DIABACT III study, and includes all patients still alive.\n\nTo evaluate their quality of life, patients and parents will answer specific questionnaries. The Pediatric Quality of Life inventory (PedSQL) has various versions for children depending on their age, adults and parents. The investigators will get physical, emotional, social and academic scores.\n\nTo assess somatic and psychological effect after the severe bacterial infection, the investigators will have telephone interviews with the parents, with many questions about organs disorders, specialized medical follow-up, medication, need physical or material assistance, financial and psychological family impact… The investigators will examine data from DIABACT III study to assess determinants of the quality of life for these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patients from DIABACT III study still alive at the beginning of this study\n\nExclusion Criteria:\n\n* Patients who did not respond to the questionnaire\n* Inability to contact the patient and family\n* No fixed postal address'}, 'identificationModule': {'nctId': 'NCT04005560', 'briefTitle': "Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection", 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': "Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection", 'orgStudyIdInfo': {'id': 'RC19_0128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patient', 'description': 'Score of PedSQL who is the Pediatric Quality of Life Questionnaire', 'interventionNames': ['Other: no interventional study']}], 'interventions': [{'name': 'no interventional study', 'type': 'OTHER', 'description': 'no interventional study', 'armGroupLabels': ['patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}