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

N/ANot Yet RecruitingNCT07160569

Fondazione Policlinico Universitario Agostino Gemelli IRCCS100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

prevalence of the susceptibility/resistance

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

Time frame: 12 months

Secondary Outcomes

Prevalence of different Sequence Type Analysis

To assess the prevalence of different Sequence Type Analysis (ST), resistome and virulome of the collected CRE isolates

Time frame: 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