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

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.

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Key information

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universtiario Agostino Gemelli IRCCS, Rome, Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)

Diagnostic Test

Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE

Other names: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE

Primary outcomes

prevalence of the susceptibility/resistance

Time frame: 12 months

prevalence of the susceptibility/resistance patterns of ceftazidime- avibactam, meropenem-vaborbactam and cefiderocol in all the CRE isolates

Secondary outcomes

Prevalence of different Sequence Type Analysis

Time frame: 12months

To assess the prevalence of different Sequence Type Analysis (ST), resistome and virulome of the collected CRE isolates
Odds ratio for the association between multiple factors

Time frame: 12 months

To assess the odds ratio for the association of the primary endpoint with demographic, clinical, and therapeutic factors

Study contacts

Contact information is provided by the study sponsor or research team.

Carlo Torti, Prof

CONTACT

[email protected]

+390630154945

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: MICE

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 8, 2025
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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