Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
Study NCT ID:
NCT02805803
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2016-06-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.', 'timeFrame': '2 years', 'description': 'Method assessment : Short Form 12 questionary (SF12)'}], 'secondaryOutcomes': [{'measure': '1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.', 'timeFrame': '2 years', 'description': 'Method assessment : Beck depression inventory (BDI)'}, {'measure': '2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.', 'timeFrame': '2 years', 'description': 'Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)'}, {'measure': '3. Evaluation of PSA side effects', 'timeFrame': '2 years', 'description': 'Method assessment : anamnesis and clinical examination'}, {'measure': '4. Evaluation of nutritional status', 'timeFrame': '2 years', 'description': 'Method assessment : BMI and proteinuria measurement'}, {'measure': '5. Evaluation of PSA termination criteria', 'timeFrame': '2 years', 'description': 'Monitoring :\n\n* Treatment failure in case of :\n\n * Side effects\n * Relapse of the infection\n * Persistance of the infection\n* The patient wishes terminate the treatment because of :\n\n * Side effects\n * The infection is controlled'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prosthetic Joint Infection']}, 'descriptionModule': {'briefSummary': 'Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation.\n\nThere is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.', 'detailedDescription': 'Main objective:\n\nQuality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.\n\nSecondary objectives:\n\n1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.\n2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.\n3. Evaluation of PSA side effects\n4. Evaluation of nutritional status\n5. Evaluation of of PSA termination criteria\n\nMethods:\n\nThe follow up oh this cohort will be conducted using 3 questionaries related to quality of life, joint stiffness and depressive symptoms.\n\nStudy type:\n\nThis is a study of health care procedure, evaluating the quality of life of patients undergoing prolonged suppressive antibiotherapy for PJI.\n\nSample size: all patients cared by our referral center of bone and joint infection, who meet protocol selection criteria will be included in the study, thus we are expecting to recruit 60 patients.\n\nStudy duration: 6 years.\n\nRecruitment period: 4 years.\n\nMaximal duration of data collection: 2 years.\n\nInvestigator center: Single center study.\n\nMean patient inclusion per year: 15 patients per year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged over 18 years old with hip or knee prosthetic infection who consented to participate in the study\n* Non-eligible patient to surgical treatment\n* Patient eligible to prolonged suppressive antibiotherapy\n\nExclusion Criteria:\n\n* patient who does not meet eligibility criteria\n* Patient living or traveling abroad for whom 2 years minimum follow up is impossible.\n* Patient lawfully deprived of his liberty\n* Patient not insured under social security scheme'}, 'identificationModule': {'nctId': 'NCT02805803', 'acronym': 'PSA-QOL', 'briefTitle': 'Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Diaconesses Croix Saint-Simon'}, 'officialTitle': 'Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.', 'orgStudyIdInfo': {'id': 'ID RCB: 2015-A01702-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Quality of life questionary', 'description': 'During this study of health and care procedure, we will assess the quality of life of patients treated with suppressive antibiotique therapy using three questionaries:\n\n* SF12\n* Beck\n* WOMAC', 'interventionNames': ['Other: Quality of life questionary']}], 'interventions': [{'name': 'Quality of life questionary', 'type': 'OTHER', 'otherNames': ['Depressive symptoms questionary', 'Joint functional questionary'], 'description': 'Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.', 'armGroupLabels': ['Quality of life questionary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Simon MARMOR, MD', 'role': 'CONTACT', 'email': 'smarmor@hopital-dcss.org', 'phone': '0033144641640'}, {'name': 'Valérie ZELLER, MD', 'role': 'CONTACT', 'email': 'vzeller@hopital-dcss.org', 'phone': '0033144641780'}], 'facility': 'Groupe Hospitalier Diaconesses Croix saint Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Younes KERROUMI, Doctorate', 'role': 'CONTACT', 'email': 'ykerroumi@hopital-dcss.org', 'phone': '01 44 64 33 84'}], 'facility': 'Groupe Hospitalier Dianconesses croix saint Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Younes KERROUMI, MD', 'role': 'CONTACT', 'email': 'ykerroumi@hopital-dcss.org', 'phone': '(+33) 1 44 64 33 84'}], 'overallOfficials': [{'name': 'Simon MARMOR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Diaconesses Croix Saint-Simon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Diaconesses Croix Saint-Simon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'SMARMOR', 'investigatorAffiliation': 'Groupe Hospitalier Diaconesses Croix Saint-Simon'}}}}