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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Qualifiers

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 design

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 3 treatment groups