About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subjects under 18 years of age
absence of CRE infections
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)
Diagnostic testWhole Genome Sequencing (WGS), Sequence Type Analysis (ST), resistome, viruloma, and phenotypic resistance of CRE
Treatment groups
Trial 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
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
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
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: