Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT07160569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of the susceptibility/resistance', 'timeFrame': '12 months', 'description': 'prevalence of the susceptibility/resistance patterns of ceftazidime- avibactam, meropenem-vaborbactam and cefiderocol in all the CRE isolates'}], 'secondaryOutcomes': [{'measure': 'Prevalence of different Sequence Type Analysis', 'timeFrame': '12months', 'description': 'To assess the prevalence of different Sequence Type Analysis (ST), resistome and virulome of the collected CRE isolates'}, {'measure': 'Odds ratio for the association between multiple factors', 'timeFrame': '12 months', 'description': 'To assess the odds ratio for the association of the primary endpoint with demographic, clinical, and therapeutic factors'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbapenem-Resistant Enterobacteriaceae Infection']}, 'descriptionModule': {'briefSummary': 'Severe infections caused by carbapenem-resistant Enterobacterales (CRE) represent a challenge for the clinicians, considering the high mortality rate of these infections. Data regarding the prevalence of CRE, clonal analysis, resistant genes (resistome) and virulence genes (virulome) molecular analyses, and clinical outcomes of infected patients are scarce. Thus, creating a network to Standardize and implement microbiological sourveillance could be crucial to answer this challenge. Our group consisting of the, UOC of Infectious Diseases and UOC of Microbiology (Prof Sanguinetti), the Microbiology Unit of the University of Catania (Prof. Stefania Stefani), the local Infectious Disease Unit (Dr Carmelo Iacobello) the Microbiology Unit of the "Magna Graecia\'\' University (Prof. Giovanni Matera) and the UOC of Infectious and Tropical Diseases UMG Catanzaro Prof Enrico Maria Trecarichi, has already started a project with promising ad interim results on this topic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients with confirmed CRE infections, defined as pathogens resistant to meropenem, ertapenem, and imipenem, assessed by EUCAST (European Committee on Antimicrobial Susceptibility Testing) and who have received at least one dose of the following drugs: ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 18 years;\n2. isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI.\n3. Patients who by clinical practice have received at least one dose of the following drugs from ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.\n4. Signature of Informed Consent\n\nExclusion Criteria:\n\n1. Subjects under 18 years of age\n2. absence of CRE infections'}, 'identificationModule': {'nctId': 'NCT07160569', 'acronym': 'MICE', 'briefTitle': 'Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales: A Prospective Multicenter Study in Southern Italy (the MICE Study)', 'orgStudyIdInfo': {'id': 'ID7409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group-ceftazidime/avibactam', 'description': '30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI.', 'interventionNames': ['Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)']}, {'label': 'Treatment group-meropenem/vaborbactam', 'description': '30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI.', 'interventionNames': ['Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)']}, {'label': 'Treatment group-cefiderocol', 'description': '30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI.', 'interventionNames': ['Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)']}], 'interventions': [{'name': 'Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE'], 'description': 'Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE', 'armGroupLabels': ['Treatment group-cefiderocol', 'Treatment group-ceftazidime/avibactam', 'Treatment group-meropenem/vaborbactam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Silvia Lamonica', 'role': 'CONTACT', 'email': 'Silvia.lamonica@policlinicogemelli.it'}], 'facility': 'Fondazione Policlinico Universtiario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Catania', 'country': 'Italy', 'contacts': [{'name': 'Carmelo Iacobello, MD', 'role': 'CONTACT'}], 'facility': 'Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Cannizzaro", Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catanzaro', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Russo, Prof', 'role': 'CONTACT'}], 'facility': 'Unit of Infectious and Tropical Diseases, University "Magna Graecia", Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'contacts': [{'name': 'Luigi Principe, MD', 'role': 'CONTACT'}], 'facility': 'Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}], 'centralContacts': [{'name': 'Carlo Torti, Prof', 'role': 'CONTACT', 'email': 'carlo.torti@policlinicogemelli.it', 'phone': '+390630154945'}], 'overallOfficials': [{'name': 'Carlo Torti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}