Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST).
- Who it may be relevant to
- Registry conditions: Carbapenem-Resistant Enterobacteriaceae Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales: A Prospective Multicenter Study in Southern Italy (the MICE Study)
Overview
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.
Interventions
- Diagnostic test Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)
Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE
Primary outcome measures
- prevalence of the susceptibility/resistance [Time frame: 12 months]
Secondary outcome measures (2)
- Prevalence of different Sequence Type Analysis [Time frame: 12months]
- Odds ratio for the association between multiple factors [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- age ≥ 18 years;
- isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI.
- Patients who by clinical practice have received at least one dose of the following drugs from ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.
- Signature of Informed Consent
Exclusion criteria
- Subjects under 18 years of age
- absence of CRE infections
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 4 centers
- Fondazione Policlinico Universtiario Agostino Gemelli IRCCS — Rome
- Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Cannizzaro", Catania — Catania
- Unit of Infectious and Tropical Diseases, University "Magna Graecia", Catanzaro — Catanzaro
- Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Bianchi-Melacrino-Morelli", — Reggio Calabria
Identifiers
NCT: NCT07160569 · ID7409