Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT04724603
Status:
RECRUITING
Last Update Posted:
2023-04-13
First Post:
2021-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phage Safety Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of patients having had an adverse event', 'timeFrame': '1 year', 'description': 'number of patients having had an adverse event'}, {'measure': 'rate of adverse event attributable to the surgery', 'timeFrame': '1 year', 'description': 'number of patients having had an adverse event because of the surgery'}, {'measure': 'type of adverse event attributable to the surgery', 'timeFrame': '1 year', 'description': "classification according to Clavien's Clasification"}, {'measure': 'rate of adverse event attributable to the antibiotic treatment', 'timeFrame': '1 year', 'description': 'number of patients having had an adverse event because of the antibiotic treatment'}, {'measure': 'rate of adverse event attributable to the phagotherapy', 'timeFrame': '1 year', 'description': 'number of patients having had an adverse event because of phagotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone and joint infection', 'phagotherapy', 'adverse event', 'Prosthetic Joint Infection'], 'conditions': ['Bone and Joint Infection', 'Prosthetic Joint Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.crioac-lyon.fr/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having had a bone or joint or implant infection treated by phagotherapy at the CRIOAc Lyon and having had an adverse event', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04724603', 'acronym': 'PHASACO-retro', 'briefTitle': 'Phage Safety Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Phage Safety Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '334'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients having had avderse event after phagotherapy for bone or joint infection', 'interventionNames': ['Other: patients having had avderse event after phagotherapy for bone or joint or implant infection']}], 'interventions': [{'name': 'patients having had avderse event after phagotherapy for bone or joint or implant infection', 'type': 'OTHER', 'description': 'to determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection', 'armGroupLabels': ['patients having had avderse event after phagotherapy for bone or joint infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Johanna Boulant, CRA', 'role': 'CONTACT', 'email': 'johanna.boulant@chu-lyon.fr', 'phone': '04 26 73 29 38'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}