Shionogi & Co., Ltd. reported CIRCE real-world data showing cefiderocol achieved 68% clinical cure and 83% day-28 survival in adults with MBL-producing Enterobacterales infections.
Written by: Dr. Anuja Badgujar, BDS
Reviewed By: Pharmacally Editorial Team
Shionogi & Co., Ltd. reported real-world findings from the CIRCE study evaluating cefiderocol in adults with metallo-beta-lactamase (MBL)-producing Enterobacterales infections. Cefiderocol is indicated for the treatment of seriously ill adult patients with complicated urinary tract infections and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain Gram-negative bacterial infections.
According to the company, the CIRCE study was a retrospective, observational, multicenter chart review conducted in Spain between January 2023 and April 2025, involving 232 adult patients. The analysis showed that 68% of patients treated with cefiderocol were clinically cured at day 14, while 82% achieved clinical response. Survival rates were 90% at day 14 and 83% at day 28. At baseline, 29% of patients were immunosuppressed, 27% were in intensive care, and 13% presented with septic shock. Drug-associated adverse events were collected through routine chart review, with no new safety signals identified beyond the established safety profile of cefiderocol.
Shionogi noted that MBL-producing Enterobacterales inactivate nearly all beta-lactam antibiotics, including carbapenems, thereby limiting therapeutic options. In the CIRCE study, the most frequently identified pathogens were carbapenem-resistant Klebsiella pneumoniae and Enterobacter species, both classified by the World Health Organization as critical priority pathogens due to high levels of resistance to currently available therapies.
Ricard Ferrer of Vall d’Hebron Hospital stated that MBL-producing Enterobacterales infections represent a significant and growing clinical challenge, particularly in critically ill patients with limited treatment options, adding that the data support the clinical effectiveness of cefiderocol and contribute real-world evidence to inform treatment considerations.
Among patients with available follow-up cultures, microbiological eradication rates were 85% in bloodstream infections and 82% in urinary tract infections. Approximately half of patients received cefiderocol based on susceptibility testing.
Additional data presented at ESCMID 2026 evaluated the in vitro activity of cefiderocol against more than 4,000 Stenotrophomonas maltophilia clinical isolates collected through the multinational SIDERO-WT (2014–2019) and SENTRY (2020–2024) surveillance programmes. Over the 10-year period, cefiderocol susceptibility remained stable, with no significant change observed before or after market introduction. Stenotrophomonas maltophilia is an opportunistic pathogen with intrinsic resistance to multiple antimicrobial classes, often limiting treatment options in high-risk patients.
Data presented at the same congress reinforced cefiderocol’s effectiveness against Stenotrophomonas maltophilia, with a subgroup analysis of 119 patients from the PROVE study demonstrating clinical cure in approximately two-thirds of patients, the majority of whom were critically ill and receiving care in intensive care units.
Mark Hill of Shionogi & Co., Ltd. stated that antimicrobial resistance continues to threaten effective treatment of serious Gram-negative infections globally and that the findings add to the growing body of evidence supporting cefiderocol in resistant pathogens while highlighting the importance of continued investment in antimicrobial innovation.
Reference
ESCMID Global 2026: Shionogi Presents New Real-World Data Highlighting Clinical Effectiveness of Fetroja®/Fetcroja® (Cefiderocol) in MBL-Producing Enterobacterales Infections https://www.shionogi.com/us/en/news/2026/04/escmid-global-2026-shionogi-presents-new-real-world-data-highlighting-clinical-effectiveness-of-fetroja-fetcroja-cefiderocol-in-mbl-producing-enterobacterales-infections.html
About the Writer
Dr. Anuja Badgujar, BDS, is a dentist with expertise in US healthcare data and medical data annotation. With four years of experience handling US healthcare datasets, she brings strong domain knowledge and precision to her work. She is also deeply passionate about medical writing, with a focus on translating complex medical information into clear and structured content.