New real-world data presented at The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2025 suggests better clinical outcomes for patients with serious Gram-negative infections when cefiderocol (Fetcroja/Fetroja) is used earlier in the treatment pathway—either as empiric or documented therapy—rather than reserved as a salvage option.

The findings are based on the European cohort of PROVE (Retrospective Cefiderocol Chart Review), the largest real-world study of cefiderocol to date. The international, five-year retrospective study reviewed medical records of 567 hospitalised adult patients across Spain, France, Italy, Germany, and the UK, all of whom received cefiderocol for at least 72 hours between November 2020 and July 2024.

Patients treated with cefiderocol for a documented infection achieved a clinical cure rate of 67.4%, and those treated empirically had a 64.6% cure rate. In comparison, patients who received cefiderocol as salvage therapy had a lower clinical cure rate of 58.2%.

According to Professor Oliver Cornely of the University of Cologne, the data highlight a potential benefit to using cefiderocol earlier in the treatment of resistant Gram-negative infections. He noted that reserving the drug as a last-line option may be associated with poorer outcomes.

Among the total cohort, 65.3% of patients achieved clinical cure. The most commonly treated infections were respiratory tract infections, reported in over half of all patients, followed by urinary tract infections. Critically ill patients made up a significant portion of the group, with 55.9% in intensive care and over 40% requiring organ support when treatment began.

The most frequent pathogens were Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacterales—all recognised by the World Health Organization as priority organisms due to their resistance profiles. Patients infected with P. aeruginosa demonstrated a particularly high clinical cure rate of 73.1%.

Cefiderocol is approved in Europe for treating aerobic Gram-negative infections in adults with limited treatment options and is also available in the US and Japan under the brand name Fetroja.

Takuko Sawada, board director and vice chair, Shionogi & Co Ltd., said: “Antimicrobial resistance is one of the most pressing global health challenges of this century, resulting in the deaths of millions of people around the world each year. In order to support better patient outcomes, it is imperative that clinicians have access to the innovative treatments they need for appropriate use with the right patient at the right time.

“We remain committed to the research and development of essential medicines that will help tackle the growing threat of drug-resistant infection.”