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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Treatment group-ceftazidime/avibactam1 intervention
Group B: Treatment group-meropenem/vaborbactam1 intervention
Group C: Treatment group-cefiderocol1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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