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Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study

  • Authors:
    • Andrea Marino
    • Emmanuele Venanzi Rullo
    • Ylenia Russotto
    • Marco Visicaro
    • Cristina Micali
    • Mariagiovanna Coco
    • Antonio Edoardo Campanella
    • Giovanni Francesco Pellicanò
    • Carmelo Iacobello
    • Giuseppe Nunnari
  • View Affiliations / Copyright

    Affiliations: Department of Clinical and Experimental Medicine, University of Catania, I‑95123 Catania, Italy, Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Messina, I‑98122 Messina, Italy, Unit of Infectious Diseases, ‘Cannizzaro’ Hospital for Emergencies, I‑95126 Catania, Italy
    Copyright: © Marino et al. This is an open access article distributed under the terms of Creative Commons Attribution License [CC BY_NC 4.0].
  • Article Number: 156
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    Published online on: July 22, 2025
       https://doi.org/10.3892/br.2025.2034
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Abstract

The increasing prevalence of multidrug‑resistant (MDR) Gram‑negative bacteria, particularly Acinetobacter baumannii (A. baumannii), represents a major clinical challenge, especially in critically ill patients. Cefiderocol, a siderophore cephalosporin, has emerged as a promising therapeutic option for infections caused by carbapenem‑resistant organisms. The present study aimed to evaluate the real‑life efficacy and safety of cefiderocol in a high‑risk hospital population. A monocentric, retrospective observational study was conducted at the University Hospital ‘Gaetano Martino’ in Messina, Italy, from July 2021 to April 2022. Adult patients treated with cefiderocol for ≥48 h for documented or suspected infections caused by MDR Gram‑negative bacteria were included. Primary endpoints were clinical resolution and mortality at discharge. Secondary outcomes included adverse drug reactions, hospital epidemiology of MDR organisms, and correlation with colonization status. Data were analyzed using descriptive and inferential statistics. A total of 55 patients were included, with a median age of 65 years; 67.3% were male. Most infections were pneumonia (80.0%) and bloodstream infections (BSI; 45.5%). A. baumannii was the most frequently isolated pathogen (87.3%), with 73.7% being extensively drug‑resistant. Clinical success was observed in 40% of ventilator‑associated pneumonia, 66.7% of BSI, and 100% of skin and soft tissue infections. Overall mortality was 47.3%, significantly associated with colonization by MDR organisms (P=0.028) and septic shock (P=0.001). No serious adverse events related to cefiderocol were reported. In conclusion, in a real‑world setting involving severely ill patients with limited therapeutic options, cefiderocol showed favorable efficacy and favorable tolerability, particularly in bloodstream and soft tissue infections. These results support its role as a valuable treatment option for MDR Gram‑negative infections, especially in intensive care unit settings, although further controlled studies are warranted.
View Figures

Figure 1

Distribution of infection sites among
patients treated with cefiderocol. BSI, bloodstream infections;
ABSSSI, acute bacterial skin and soft tissue infections; IAI,
intra-abdominal infections; UTI, urinary tract infections; CNS,
central nervous system.

Figure 2

Distribution of main resistance
mechanisms among Gram-negative pathogens isolated in patients
treated with cefiderocol. CRAB, carbapenem-resistant
Acinetobacter baumannii; KPC, Klebsiella pneumoniae
carbapenemase; ESBL, extended-spectrum beta-lactamase.

Figure 3

Empiric antibiotic treatments
administered prior to cefiderocol.

Figure 4

Antibiotics' combination along with
cefiderocol.
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Copy and paste a formatted citation
Spandidos Publications style
Marino A, Venanzi Rullo E, Russotto Y, Visicaro M, Micali C, Coco M, Campanella AE, Pellicanò GF, Iacobello C, Nunnari G, Nunnari G, et al: Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study. Biomed Rep 23: 156, 2025.
APA
Marino, A., Venanzi Rullo, E., Russotto, Y., Visicaro, M., Micali, C., Coco, M. ... Nunnari, G. (2025). Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study. Biomedical Reports, 23, 156. https://doi.org/10.3892/br.2025.2034
MLA
Marino, A., Venanzi Rullo, E., Russotto, Y., Visicaro, M., Micali, C., Coco, M., Campanella, A. E., Pellicanò, G. F., Iacobello, C., Nunnari, G."Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study". Biomedical Reports 23.4 (2025): 156.
Chicago
Marino, A., Venanzi Rullo, E., Russotto, Y., Visicaro, M., Micali, C., Coco, M., Campanella, A. E., Pellicanò, G. F., Iacobello, C., Nunnari, G."Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study". Biomedical Reports 23, no. 4 (2025): 156. https://doi.org/10.3892/br.2025.2034
Copy and paste a formatted citation
x
Spandidos Publications style
Marino A, Venanzi Rullo E, Russotto Y, Visicaro M, Micali C, Coco M, Campanella AE, Pellicanò GF, Iacobello C, Nunnari G, Nunnari G, et al: Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study. Biomed Rep 23: 156, 2025.
APA
Marino, A., Venanzi Rullo, E., Russotto, Y., Visicaro, M., Micali, C., Coco, M. ... Nunnari, G. (2025). Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study. Biomedical Reports, 23, 156. https://doi.org/10.3892/br.2025.2034
MLA
Marino, A., Venanzi Rullo, E., Russotto, Y., Visicaro, M., Micali, C., Coco, M., Campanella, A. E., Pellicanò, G. F., Iacobello, C., Nunnari, G."Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study". Biomedical Reports 23.4 (2025): 156.
Chicago
Marino, A., Venanzi Rullo, E., Russotto, Y., Visicaro, M., Micali, C., Coco, M., Campanella, A. E., Pellicanò, G. F., Iacobello, C., Nunnari, G."Real‑world effectiveness and safety of cefiderocol in critically ill patients with MDR Gram‑negative infections: Results from a retrospective study". Biomedical Reports 23, no. 4 (2025): 156. https://doi.org/10.3892/br.2025.2034
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