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

NCT ID: NCT07160569

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-08-31

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.

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: DIAGNOSTIC_TEST

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

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.

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

Intervention Type: DIAGNOSTIC_TEST

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

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.

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Torti

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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

Countries

Italy

Central Contacts

Carlo Torti, Prof

Role: CONTACT

carlo.torti@policlinicogemelli.it

+390630154945

Facility Contacts

Silvia Lamonica

Role: primary

Silvia.lamonica@policlinicogemelli.it

Carmelo Iacobello, MD

Role: primary

Alessandro Russo, Prof

Role: primary

Luigi Principe, MD

Role: primary

Other Identifiers

ID7409

Identifier Type: -

Identifier Source: org_study_id