Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07160569
Acronym
MICE
Enrollment
100
Registered
2025-09-08
Start date
2025-09-01
Completion date
2026-08-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Brief 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.

Interventions

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

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age ≥ 18 years; 2. isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI. 3. Patients who by clinical practice have received at least one dose of the following drugs from ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol. 4. Signature of Informed Consent

Exclusion criteria

1. Subjects under 18 years of age 2. absence of CRE infections

Design outcomes

Primary

MeasureTime frameDescription
prevalence of the susceptibility/resistance12 monthsprevalence of the susceptibility/resistance patterns of ceftazidime- avibactam, meropenem-vaborbactam and cefiderocol in all the CRE isolates

Secondary

MeasureTime frameDescription
Prevalence of different Sequence Type Analysis12monthsTo assess the prevalence of different Sequence Type Analysis (ST), resistome and virulome of the collected CRE isolates
Odds ratio for the association between multiple factors12 monthsTo assess the odds ratio for the association of the primary endpoint with demographic, clinical, and therapeutic factors

Countries

Italy

Contacts

Primary ContactCarlo Torti, Prof
carlo.torti@policlinicogemelli.it+390630154945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026