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

NCT07160569 | Not Yet Recruiting DMC

• 1 other identifier: ID7409
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• prevalence of the susceptibility/resistance

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

  12 months

Secondary Outcomes (2)

• Prevalence of different Sequence Type Analysis

  12months

• Odds ratio for the association between multiple factors

  12 months

Study Arms (3)

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.

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.

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.

Diagnostic Test: Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)

Interventions

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

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

Treatment group-cefiderocol; Treatment group-ceftazidime/avibactam; Treatment group-meropenem/vaborbactam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Subjects under 18 years of age
• absence of CRE infections

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (4)

Fondazione Policlinico Universtiario Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Cannizzaro", Catania

Catania, Italy

Location

Unit of Infectious and Tropical Diseases, University "Magna Graecia", Catanzaro

Catanzaro, Italy

Location

Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria

Reggio Calabria, Italy

Location

Study Officials

• Carlo Torti

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Torti, Prof

CONTACT

+390630154945; carlo.torti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)