Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT05883995
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2023-05-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Avis-PHAGEinLYON Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of phage therapy requests', 'timeFrame': 'at inclusion', 'description': 'Number of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028 per year and per month.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bacteriophage', 'medical advice'], 'conditions': ['Bone Infection']}, 'referencesModule': {'references': [{'pmid': '39491599', 'type': 'DERIVED', 'citation': 'Ferry T, Bouar ML, Briot T, Roussel-Gaillard T, Perpoint T, Roux S, Ader F, Valour F, Kassai B, Boussaha I, Ndiaye M, Craighero F, Javaux C, Lustig S, Batailler C; PHAGEinLYON Clinic Study Group. Access to phage therapy at Hospices Civils de Lyon in 2022: Implementation of the PHAGEinLYON Clinic programme. Int J Antimicrob Agents. 2024 Dec;64(6):107372. doi: 10.1016/j.ijantimicag.2024.107372. Epub 2024 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 patients will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1500 patients with severe infection treated with phagotherapy will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patient referred to the Hospices Civils de Lyon for a phage therapy request from 01/01/2015 to 01/01/2028.\n* Avis-PHAGEinLYON clinic study information notice provided to the patient\n\nExclusion Criteria:\n\n* \\- Opposition of trial participant'}, 'identificationModule': {'nctId': 'NCT05883995', 'briefTitle': 'Avis-PHAGEinLYON Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Avis-PHAGEinLYON Clinic', 'orgStudyIdInfo': {'id': '23-5092'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phage therapy requests', 'type': 'OTHER', 'description': 'Quantification of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69317', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tristan FERRY, MD, PhD', 'role': 'CONTACT', 'email': 'tristan.ferry@chu-lyon.fr', 'phone': '0472071107', 'phoneExt': '+33'}, {'name': 'Johanna BOULANT, ARC', 'role': 'CONTACT', 'email': 'johanna.boulant@chu-lyon.fr', 'phone': '0426732938', 'phoneExt': '+33'}], 'facility': 'Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Tristan FERRY, MD', 'role': 'CONTACT', 'email': 'Tristan.ferry@chu-lyon.fr', 'phone': '0033 4.72.07.11.07'}, {'name': 'Myrtille LE BOUAR, CRA', 'role': 'CONTACT', 'email': 'myrtille.le-bouar@chu-lyon.fr', 'phone': '+33 (0)4 72 00 63 33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}