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NOT YET RECRUITING
NCT07160569

Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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.

Official title: Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales: A Prospective Multicenter Study in Southern Italy (the MICE Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-09-01

Completion Date

2026-08-31

Last Updated

2025-09-08

Healthy Volunteers

No

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

Locations (4)

Fondazione Policlinico Universtiario Agostino Gemelli IRCCS

Rome, Roma, Italy

Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Cannizzaro", Catania

Catania, Italy

Unit of Infectious and Tropical Diseases, University "Magna Graecia", Catanzaro

Catanzaro, Italy

Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria

Reggio Calabria, Italy