Key Highlights:
- Shionogi & Co., Ltd. shared new data at IDWeek 2024 from the PROVE study, the largest global real-world evidence review of Fetroja/Fetcroja (cefiderocol).
- The study looked at how cefiderocol is used to treat seriously ill adult patients with certain Gram-negative bacterial infections, most of which were resistant to carbapenem antibiotics.
- 75.1% of the patients in the study had a favourable clinical response to cefiderocol at the end of treatment and the rate of 30-day all-cause mortality (ACM) was 23.3%.
Shionogi & Co., Ltd. shared new data at IDWeek 2024 from the PROVE study, the largest global real-world evidence review of Fetroja/Fetcroja (cefiderocol). The study looked at how cefiderocol, a unique antibiotic, is used to treat seriously ill adult patients with certain Gram-negative bacterial infections, most of which were resistant to carbapenem antibiotics.
PROVE is an international, multicentre, retrospective medical chart review study designed to describe the patient characteristics and clinical outcomes in patients treated with cefiderocol for GN bacterial infections in real-world settings between 2020 and 2024. Of the patients included in the analysis, 75.1% had a favourable clinical response to cefiderocol at the end of treatment (defined as resolution or improvement of signs and symptoms as judged by the physician, excluding deaths while on therapy).
“Seriously ill patients with resistant Gram-negative bacterial infections are often difficult to treat. Although antibiotics are usually approved based on data from randomised controlled clinical trials, clinicians often rely on real-world evidence data to understand how antibiotics may perform in clinical settings,” said Cornelius (Neil) Clancy, MD, professor of Medicine, University of Pittsburgh. “This real-world evidence from PROVE, the largest to date for cefiderocol, further support its use and importance as a treatment option for appropriate patients with carbapenem-resistant Gram-negative infections in clinical settings.”
This analysis included 1,075 hospitalised patients, the majority (56.6%) of whom were in the intensive care unit and had a median age of 60 (range from 46-69 years). The majority (53.1%) of patients had respiratory tract infections (RTIs), 10.6% of patients had urinary tract infections (UTIs), and 10% of patients had bloodstream infections. Additionally, 74.6% of infections were resistant to carbapenems, antibiotic agents commonly used for treatment of severe bacterial infections. Of monomicrobial infections, the predominant pathogen was Pseudomonas aeruginosa (35.9%) followed by Acinetobacter baumannii (18.1%), and Enterobacterales (13.1%). Also a quarter of patients (25.2%) had polymicrobial infections, where an infection involved multiple concurrent Gram-negative pathogens.
Clinical response rates were 71.6% in patients with RTI, 74.1% in patients with bloodstream infections and 91.2% in patients with UTIs. Overall, the rate of 30-day all-cause mortality (ACM) was 23.3%. There were 29 adverse drug reactions (ADRs) across 25 patients, including three serious ADRs. Of the 1,075 patients, 13 patients discontinued treatment with cefiderocol due to adverse drug reactions.