NCT07160569

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-01
• Completion: 2026-08-31
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

4 sites across 1 country: Italy