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Clinical Trials in Italy / NCT07160569
Starting soon Observational

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

NCT07160569 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2025-09-01
Last updated
2025-09-08

Condition(s) studied

Carbapenem-Resistant Enterobacteriaceae Infection

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • prevalence of the susceptibility/resistance — 12 months
    prevalence of the susceptibility/resistance patterns of ceftazidime- avibactam, meropenem-vaborbactam and cefiderocol in all the CRE isolates

Trial sites (4)

FacilityCityRegionStatus
Fondazione Policlinico Universtiario Agostino Gemelli IRCCS Rome Roma
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07160569 on ClinicalTrials.gov ↗ ← All trials in Italy