Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06185920
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PHAGEinLYON Clinic Cohort Study: a Descriptive Study of Severe Infections Treated With Phage Therapy at the HCL.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2034-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of each type of severe infection', 'timeFrame': 'through study completion (5years)', 'description': 'Rate of each type of severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bacteriophage', 'severe infection'], 'conditions': ['Severe Infection']}, 'descriptionModule': {'briefSummary': 'PHAGEinLYON Clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients with a severe infection treated with bacteriophage in the Hospices civils de Lyon from 2015 to 2033. The primary objective is to describe the severe infections treated with phagotherapy. 250 patients will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '250 patients with severe infection treated with phagotherapy will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 01/01/2015 to 01/01/2033\n* PHAGEinLYON Clinic cohort study information notice provided to the patient\n\nExclusion Criteria:\n\n* Opposition of trial participant'}, 'identificationModule': {'nctId': 'NCT06185920', 'briefTitle': 'PHAGEinLYON Clinic Cohort Study: a Descriptive Study of Severe Infections Treated With Phage Therapy at the HCL.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Non Interventional Retrospective and Prospective Single Center Descriptive Study of Severe Infections Treated With Phage Therapy at the Hospices Civils de Lyon (PHAGEinLYON Clinic Cohort Study).', 'orgStudyIdInfo': {'id': '69HCL23_0189'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with severe infection.', 'description': 'Patients with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.', 'interventionNames': ['Other: Description of severe infection']}], 'interventions': [{'name': 'Description of severe infection', 'type': 'OTHER', 'description': 'Description of severe infections treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.', 'armGroupLabels': ['Patients with severe infection.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tristan FERRY, Pr', 'role': 'CONTACT', 'email': 'tristan.ferry@chu-lyon.fr', 'phone': '04 72 07 24 81', 'phoneExt': '+33'}, {'name': 'Tristan FERRY, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}