System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Observational Not yet recruiting

NCT07160569 on ClinicalTrials.gov

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

Official title: Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales: A Prospective Multicenter Study in Southern Italy (the MICE Study)

  • Sponsor: Agostino Gemelli University Polyclinic
  • Enrollment: 100 (Estimated)
  • Study start: 2025-09-01 (Estimated)
  • Primary completion: 2026-07-01 (Estimated)
  • Study completion: 2026-08-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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.

Conditions

  • Carbapenem-Resistant Enterobacteriaceae Infection

Intervention / Treatment

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

Primary Outcome Measures

  • prevalence of the susceptibility/resistance (12 months)
    prevalence of the susceptibility/resistance patterns of ceftazidime- avibactam, meropenem-vaborbactam and cefiderocol in all the CRE isolates

Countries

Italy

Locations and Investigators

  • Fondazione Policlinico Universtiario Agostino Gemelli IRCCS, Rome, Italy
    • Silvia Lamonica
  • Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Cannizzaro", Catania, Catania, Italy
    • Carmelo Iacobello, MD
  • Unit of Infectious and Tropical Diseases, University "Magna Graecia", Catanzaro, Catanzaro, Italy
    • Alessandro Russo, Prof
  • Unit of Infectious and Tropical Diseases, Azienda Ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria, Reggio Calabria, Italy
    • Luigi Principe, MD

Study Officials