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. 2025 Oct 16;25(1):1339.
doi: 10.1186/s12879-025-11573-3.

Cefiderocol therapy among immunocompromised adult patients: a descriptive analysis from a prospective, multicentre cohort study

Andrea Lombardi  1   2 , Daniele Roberto Giacobbe  3   4 , Davide Mangioni  2 , Bianca Mariani  2 , Antonio Muscatello  2 , Marco Muccio  5 , Chiara Aldieri  6 , Federica Briano  7 , Bruno Cacopardo  8 , Alessandra Calabresi  9 , Federico Capra Marzani  10 , Anna Carretta  11 , Annamaria Cattelan  12 , Luca Ceccarelli  13   14 , Giovanni Cenderello  15 , Silvia Corcione  16   17 , Andrea Cortegiani  18   19 , Rosario Cultrera  20   21 , Francesco Giuseppe De Rosa  16 , Valerio Del Bono  6 , Filippo Del Puente  22 , Chiara Fanelli  23 , Fiorenza Fava  24 , Daniela Francisci  25 , Nicholas Geremia  26   27 , Lucia Graziani  28 , Angela Raffaella Losito  29 , Ivana Maida  23 , Andrea Marino  8 , Maria Mazzitelli  12 , Marco Merli  30 , Roberta Monardo  31   32 , Alessandra Mularoni  33 , Chiara Oltolini  30 , Carlo Pallotto  25 , Emanuele Pontali  22 , Francesca Raffaelli  29 , Matteo Rinaldi  13   14 , Marco Ripa  31   32 , Teresa Antonia Santantonio  11 , Francesco Saverio Serino  34 , Michele Spinicci  28   35 , Carlo Torti  29   36 , Enrico Maria Trecarichi  37   38   39 , Mario Tumbarello  40   41 , Malgorzata Mikulska  42   5 , Antonio Vena  42   5 , Alessandra Bandera  1   2 , Matteo Bassetti  42   5 ; CEFI-SITA investigators
Collaborators, Affiliations

Cefiderocol therapy among immunocompromised adult patients: a descriptive analysis from a prospective, multicentre cohort study

Andrea Lombardi et al. BMC Infect Dis. .

Abstract

Purpose: The global rise in infections due to multidrug-resistant Gram-negative bacteria (MDRGNB) infections has disproportionately impacted immunocompromised (IC) hosts. Cefiderocol, a novel siderophore cephalosporin, exhibits potent activity against MDRGNB, but limited data exist on its use in IC patients. This study aimed to describe cefiderocol use in IC patients.

Methods: Patients and therapy characteristics were descriptively reported, and outcomes were compared between IC and non-IC patients. Cox regression models were used to identify factors associated with mortality.

Results: Among 185 patients, 84 (45.4%) were IC. Similar descriptive rates were observed in IC and non-IC groups regarding indications for cefiderocol use, choice of monotherapy versus combination therapy, or empirical versus targeted treatment. The 28-day clinical cure rates were similar across patients receiving targeted cefiderocol therapy for infection due to Pseudomonas aeruginosa (81%, 17/21), Enterobacterales (77.3%, 17/22) and Acinetobacter baumannii (42%, 21/50). Thirty-day mortality was comparable between IC and non-IC patients (40.8%, 95% confidence interval [CI] 27.9–56.8 vs 33.3%, 95% CI 22.9–46.9; p = 0.5430). In multivariable analysis IC status was not associated with higher mortality.

Conclusion: Cefiderocol use in IC patients resulted in clinical outcomes comparable to non-IC patients when treating MDRGNB infections. IC status was not associated with an increased mortality, emphasising the importance of effective antimicrobial therapy. Further investigation is needed to clarify the relative impact of the administered treatment vs. the patients’ clinical condition in influencing the prognosis of Acinetobacter baumannii infections.

Supplementary Information: The online version contains supplementary material available at 10.1186/s12879-025-11573-3.

Keywords: Antibiotic therapy; Antimicrobial resistance; Cefiderocol; Mortality; SOT.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The MULTI-SITA project was conducted according to the guidelines of the Declaration of Helsinki and approved by the ethics committee of the coordinating centre (Liguria Region Ethics Committee, registry number 390/2020). The amendment authorising the conduct of the CEFI-SITA study within the MULTI-SITA project was approved by the Liguria Region Ethics Committee on 12 April 2022. The other participating centres followed the local ethical committees’ requirements and prospectively enrolled patients once activated. All conscious patients at enrolment signed an informed consent to participate in the study. A waiver of informed consent for data collection from unconscious patients at the time of enrolment due to severe clinical conditions was obtained within the Liguria Region Ethics Committee approval, in line with the observational nature of the analyses and in order not to bias research results towards high cure rates and low mortality prejudicing scientific validity. Consent for publication: Not applicable. Competing interests: Outside the submitted work, Andrea Lombardi has received travel grant from Gilead Sciences, Takeda and Shionogi Inc., research grant from Gilead Sciences. Outside the submitted work, Daniele Roberto Giacobbe reports investigator-initiated grants from Pfizer, BioMérieux, and Gilead Italia, and speaker/advisor fees from Pfizer, Menarini, and Tillotts Pharma. Outside the submitted work, Matteo Bassetti has received funding for scientific advisory boards, travel, and speaker honoraria from Cidara, Gilead, Menarini, MSD, Mundipharma, Pfizer, and Shionogi. Outside the submitted work, Andrea Cortegiani received fees for lectures/scientific advisory board from Gilead, Mundipharma, MSD, Pfizer. Outside the submitted work, Enrico Maria Trecarichi reports advisor fee from MSD Italia.

Figures

Fig. 1
Fig. 1
Kaplan_Meier curves in patients with cefiderocol targeted treatment for Enterobacterales, P. aeruginosa, or A. baumannii infections (IC vs. non-IC). The time of origin was set on the day of cefiderocol initiation. Death was the event of interest, and right-censoring was applied at the end of follow-up (hospital discharge or day 30, whichever came first). Site/s of Enterobacterales infection: bloodstream infection (n = 11); lower respiratory tract infection (n = 7); urinary tract infection (n = 2); skin and soft tissue infection (n = 1); intra-abdominal infection (n = 1); more than one indication (n = 3). Site/s of P. aeruginosa infection: lower respiratory tract infection (n = 11); bloodstream infection (n = 6); urinary tract infection (n = 2); intra-abdominal infection (n = 1); skin and soft tissue infection (n = 1); more than one indication (n = 2). Site/s of A. baumannii infection: lower respiratory tract infection (n = 27); bloodstream infection (n = 26); bone and joint infection (n = 2); urinary tract infection (n = 2); intra-abdominal infection (n = 1); more than one indication (n = 2); site/s not reported (n = 1)
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