Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of different Sequence Type Analysis | To assess the prevalence of different Sequence Type Analysis (ST), resistome and virulome of the collected CRE isolates | 12months |
| Odds ratio for the association between multiple factors |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Torti, Prof | Contact | +390630154945 | carlo.torti@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Torti | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universtiario Agostino Gemelli IRCCS | Rome | Roma | 00168 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
To assess the odds ratio for the association of the primary endpoint with demographic, clinical, and therapeutic factors
| 12 months |
| 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 |
|