Carbapenem-Resistant Enterobacteriaceae InfectionMICENCT07160569
Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales
An observational study of Carbapenem-Resistant Enterobacteriaceae Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Infection
- What is being tested?
- Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)
- How many people
- 100 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with confirmed CRE infections, defined as pathogens resistant to meropenem, ertapenem, and imipenem, assessed by EUCAST (European Committee on Antimicrobial Susceptibility Testing) and who have received at least one dose of the following drugs: ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.
Who may be able to join
- 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
Who cannot join
- Subjects under 18 years of age
- absence of CRE infections
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites
Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Cannizzaro", Catania
Catania
Carmelo Iacobello, MD
Unit of Infectious and Tropical Diseases, University "Magna Graecia", Catanzaro
Catanzaro
Alessandro Russo, Prof
Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria
Reggio Calabria
Luigi Principe, MD
Fondazione Policlinico Universtiario Agostino Gemelli IRCCS
Rome, Roma, 00168
Silvia Lamonica, Silvia.lamonica@policlinicogemelli.it
About this study
Official title: Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales: A Prospective Multicenter Study in Southern Italy (the MICE Study)
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.
- Being tested
- Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)Diagnostic test
Also called Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE
Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE
| Study group | Role | What they receive |
|---|---|---|
| Treatment group-ceftazidime/avibactam | 30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI. Receives: Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST) | |
| Treatment group-meropenem/vaborbactam | 30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI. Receives: Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST) | |
| Treatment group-cefiderocol | 30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI. Receives: Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of the susceptibility/resistance
prevalence of the susceptibility/resistance patterns of ceftazidime- avibactam, meropenem-vaborbactam and cefiderocol in all the CRE isolates
Measured: 12 months
Secondary outcomes (2)
Prevalence of different Sequence Type Analysis
To assess the prevalence of different Sequence Type Analysis (ST), resistome and virulome of the collected CRE isolates
Measured: 12months
Odds ratio for the association between multiple factors
To assess the odds ratio for the association of the primary endpoint with demographic, clinical, and therapeutic factors
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Torti, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160569
- Sponsor's protocol ID
- ID7409
- Acronym
- MICE
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales: A Prospective Multicenter Study in Southern Italy (the MICE Study)
- ClinicalTrials.gov ID
- NCT07160569
- Acronym / sponsor ID
- MICE / ID7409
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group-ceftazidime/avibactam | – | Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI. |
| Treatment group-meropenem/vaborbactam | – | Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI. |
| Treatment group-cefiderocol | – | Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)30 patients receiving this treatment, isolation of CRE from a clinically relevant sample considered to be the site of infection: pneumonia, UTI, IAI, spondylodiscitis and BSI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with confirmed CRE infections, defined as pathogens resistant to meropenem, ertapenem, and imipenem, assessed by EUCAST (European Committee on Antimicrobial Susceptibility Testing) and who have received at least one dose of the following drugs: ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects under 18 years of age
- absence of CRE infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)Also: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CREWhole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE | Diagnostic test | Treatment group-cefiderocol, Treatment group-ceftazidime/avibactam, Treatment group-meropenem/vaborbactam |
Primary outcome
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
2 secondary outcomes
Prevalence of different Sequence Type Analysis
Time frame: 12months
Odds ratio for the association between multiple factors
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo Torti principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbapenem-Resistant Enterobacteriaceae Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo Torti, Prof (+390630154945, carlo.torti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of the susceptibility/resistance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.