Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-28 @ 6:53 PM
Study NCT ID:
NCT06219135
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2023-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'For each participant, a strain of the detected pathogen will be stored at the Institut des Agents Infectieux of the Centre de Biologie and Pathologie Nord of the Hôpital de la Croix Rousse 69004 Lyon.\n\nIn option, for adult patients with Bacteraemia (bacteraemia group only), a blood sample will be drawn at visit H24-48 and J30. Analysis will be done at Laboratoire Commun de Recherche Hospices Civils de Lyon-bioMérieux, 69310 Pierre Bénite'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1372}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The IDBIORIV method will be compared with the current routine methods present in the Hospices Civils de Lyon. The sensitivity and specificity of the IDBIORIV method will be evaluated using the Identification (ID) results of a positive blood culture for a', 'timeFrame': '24 Hours to 48 Hours after inclusion', 'description': 'Reference technique used = Vitek MS ® (MALDI-ToF) bioMérieux.'}, {'measure': 'The IDBIORIV method will be compared with the current routine methods present in the Hospices Civils de Lyon. The sensitivity and specificity of the IDBIORIV method will be evaluated using AST results. Reference technique = Vitek 2® bioMérieux', 'timeFrame': '24 Hours to 48 Hours after inclusion', 'description': 'The performance of the IDBIORIV method for in vitro diagnosis of antibiotic-resistant/susceptible status will be evaluated for each "species-antibiotic" pair and "species-antibiotic group" of interest.\n\nSensitivity will be calculated as the proportion of pairs diagnosed as resistant using the IDBIORIV method among pairs diagnosed as resistant using AST.\n\nSpecificity will be calculated as the proportion of pairs diagnosed as sensitive with the IDBIORIV method among pairs diagnosed as sensitive with AST.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'bacteria', 'microbiology diagnosis method', 'identification', 'resistance', 'antibiotic susceptibility testing', 'virulence'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Sepsis is a disruption of homeostasis in the human body in response to bloodstream infection and is associated with a high risk of mortality.\n\nWorldwide, sepsis is affecting approximately 30 million people and resulting in six million deaths.\n\nBlood culture is a specific blood sample used to identifying microbial agent (bacterium or yeast) and determine the sensitivity of these microorganisms to antibiotics and antifungals.\n\nAny delay in identifying the microorganism and/or determining the AST (antibiotic susceptibility testing) has a direct impact on the administration of appropriate antibiotic treatment and, consequently, on mortality of the patient. The faster the diagnosis, the faster the antibiotic treatment will be adapted, the higher the survival rate/probability of patients, and the lower the ecological impact.\n\nIn routine, clinical microbiology laboratories currently use 2 automatized techniques: MALDI-TOF MS® for microorganisms identification and VITEK2® method for AST determination.\n\nBased on a proteomic approach, the IDBIORIV method is a rapid method (90 minutes) in comparison of current methods (24/48 hours) able to identifying a large panel of 113 pathogens and determine the antibiotic resistance profile of 49 species for 4 classes of antibiotics (Beta-lactams, Aminosides, Glycopeptides, Colistin).\n\nThe main objective of this study is to evaluate the performance of the IDBIORIV method in pathogen identification and antibiotic susceptibility testing in comparison with current methods of analysis of positive blood cultures used at the microbiology laboratory of the Hospices Civils de Lyon, in a real clinical situation, over a 2-year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will focus on adult and pediatric patients hospitalized in 23 clinical departments of the Hospices Civils de Lyon and presenting a first positive blood culture detected on the microbiology laboratory of the Institut des Agents Infectieux.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult or child patient\n* Hospitalized in one of the departments registered with Hospices Civils de Lyon\n* Showing signs of infection\n* Confirmed by a 1st positive blood culture\n* Patient or close relative (trustworthy person or family member) or holder of parental authority who has given his or her non-objection after receiving the information note\n\nExclusion Criteria:\n\n* Patients under court protection\n* Patients under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT06219135', 'acronym': 'IDBIORIV', 'briefTitle': 'Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis', 'orgStudyIdInfo': {'id': '69HCL23_0542'}, 'secondaryIdInfos': [{'id': '2023-A01260-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Contamination', 'description': 'Patients with a positive blood culture due to contamination microorganism', 'interventionNames': ['Other: no intervention - Contamination group']}, {'label': 'Bacteraemia', 'description': 'This group includes all adults and children with a positive blood culture due to pathogen microorganism', 'interventionNames': ['Biological: blood sample - Bacteraemia group']}, {'label': 'Emergency', 'description': "Emergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism", 'interventionNames': ['Other: no intervention - Emergency group']}], 'interventions': [{'name': 'no intervention - Contamination group', 'type': 'OTHER', 'description': 'there is no intervention for this group of patients', 'armGroupLabels': ['Contamination']}, {'name': 'blood sample - Bacteraemia group', 'type': 'BIOLOGICAL', 'description': 'for adult patients, in optional, blood sample will be taken. 27,5 ml of blood at H24-48 after inclusion and 5 ml of blood at day 30', 'armGroupLabels': ['Bacteraemia']}, {'name': 'no intervention - Emergency group', 'type': 'OTHER', 'description': 'there is no intervention for this group of patients', 'armGroupLabels': ['Emergency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69394', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne JAVOUHAY, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Femme Mère enfant Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69394', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marine BUTIN, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Femme Mère Enfant Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69394', 'city': 'Bron', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves GILLET', 'role': 'CONTACT'}, {'name': 'Yves GILLET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Femme Mère enfant Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69394', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric BONNEFOY CUDRAZ, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Louis Pradel Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69394', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Luc FELLAHI, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Louis Pradel Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69394', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles RIOUFOL, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Louis Pradel Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69394', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic DAILLER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pierre Wertheimer Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Claire LUKASZEWICZ, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent ARGAUD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Magali AUBINEAU, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karim TAZAROURTE', 'role': 'CONTACT', 'email': 'karim.tazarourte@chu-lyon.fr'}, {'name': 'Karim TAZAROURTE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence ADER, Pr', 'role': 'CONTACT'}, {'name': 'Florence ADER, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre LANTELME, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Céline GUICHON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain Gaujard, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal SEVE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Christophe RICHARD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain HERNU', 'role': 'CONTACT', 'email': 'romain.hernu@chu-lyon.fr'}, {'name': 'Romain HERNU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnaud FRIGGERI, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lyon Sud Hospital', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle DURIEU, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lyon Sud Hospital', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franck PLAISANT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lyon Sud Hospital', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Pierre-Bénite', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion DOUPLAT', 'role': 'CONTACT', 'email': 'marion.douplat@chu-lyon.fr'}, {'name': 'Marion DOUPLAT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lyon Sud Hospital', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69100', 'city': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain SARCIRON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charpennes Hospital', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'centralContacts': [{'name': 'François VANDENESCH, Pr', 'role': 'CONTACT', 'email': 'francois.vandenesch@univ-lyon1.fr', 'phone': '4 72 07 11 11', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'François VANDENESCH, Pr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospices Civils LYON'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}