- Real world evidence study carried out in Spain demonstrates 68% clinical cure rate at day 14, and 83% overall survival at day 28, for patients infected with highly resistant metallo-beta lactamase (MBL)-producing pathogens[1]
- Carbapenem-resistant Enterobacterales pathogens are considered by the World Health Organization to be one of the most critical health threats[2]
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereafter “Shionogi”) presents new real-world data evaluating Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, in adults with confirmed MBL-producing Enterobacterales infections at the 36th Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich,17th-21st April, 20261.
The CIRCE study was a retrospective, observational, multicentre study conducted in Spain between January 2023 and April 2025, designed to describe the efficacy of real-world cefiderocol use in 232 adult patients with infections caused by MBL-producing Enterobacterales1.
The analysis found 68% of patients who received cefiderocol were considered clinically cured at day 14 and 82% of patients achieving a positive clinical response at day 141. The overall rates of survival at days 14 and 28 were 90% and 83%, respectively, in this population1. At baseline, 29% of patients were immunosuppressed, 27% were in intensive care and 13% presented with septic shock1.
MBL-producing Enterobacterales inactivate almost all beta-lactam antibiotics, including carbapenems – agents typically reserved for severe or high-risk infections, thereby limiting therapeutic options[3],[4]. In the CIRCE study, the most frequently identified pathogens were carbapenem-resistant Klebsiella pneumoniae and Enterobacter spp. respectively1, both classified by the World Health Organisation as critical priority pathogens due to their high levels of resistance to currently available therapies2.
Dr Ricard Ferrer, Head of the Intensive Care Department at Vall d’Hebron Hospital in Barcelona, Spain, said: “MBL-producing Enterobacterales infections represent a significant and growing clinical challenge worldwide, particularly in critically ill patients where treatment options are limited. These data support the clinical effectiveness of cefiderocol in adult patients with these infections, contributing further real-world evidence to inform future treatment considerations in practice.”
Among patients with available follow-up cultures, microbiological eradication rates were reported as 85% in bloodstream infections and 82% in urinary tract infections (UTIs)1. Approximately half of patients received cefiderocol based on the results of susceptibility testing1.
Additional data presented at ESCMID 2026 evaluated the in vitro activity of cefiderocol against over 4000 Stenotrophomonas maltophilia clinical isolates collected through the multinational SIDER0-WT (2014–2019) and SENTRY (2020–2024) surveillance programmes[5]. Across this ten-year period, cefiderocol demonstrated consistently high activity, with no significant change in susceptibility observed before or after market introduction6. Stenotrophomonas maltophilia is an opportunistic pathogen with intrinsic resistance to multiple antimicrobial classes, often limiting treatment options in high-risk patients6.
Data presented at the same congress reinforced cefiderocol’s efficacy 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[6].
Dr Mark Hill, global head of medical affairs at Shionogi, said: “Antimicrobial resistance continues to threaten effective treatment of serious Gram-negative infections globally. These data add to the growing body of evidence supporting cefiderocol in resistant pathogens and underscores the importance of sustained investment in innovation and evidence generation in antimicrobials.”
