Vol.73 No.S-1 April 2025
Use of cefiderocol in real-world clinical practice
1)Department of Infection Control and Laboratory Medicine, Sapporo Medical University School of Medicine, 16 Nishi, Minami 1-jyo, Chuo-ku, Sapporo, Hokkaido, Japan
2)Department of Emergency and Critical Care Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University
3)Department of Infectious Diseases, Hiroshima University Hospital
Abstract
The efficacy and safety of cefiderocol (CFDC) in various infections caused by Gram-negative bacteria have been evaluated in three global clinical trials (APEKS-cUTI, APEKS-NP, and CREDIBLE-CR), and CFDC is expected to serve as a new treatment option for refractory infections caused by carbapenem-resistant bacteria. However, since the CREDIBLE-CR study reported higher mortality in the CFDC group than in the control group for of patients with infections caused by Acinetobacter baumannii, further research is needed to evaluate the efficacy and safety of CFDC in actual clinical practice.
Database studies and observational studies based on real-world clinical practice have been conducted, mainly in Europe and the United States. The PROVE study, a multicenter, retrospective observational study in Europe and the United States, reported clinical information obtained from patients who had received CFDC for the first time in routine clinical practice to treat infections caused by Gram-negative bacteria. The interim analysis of the United States revealed a clinical cure rate in 64.8% (158/244) of the cases and a clinical response rate of 74.2% (181/244), both of which were similar to the results reported by other studies.
The meta-analyses of randomized clinical trials and observational studies were conducted by two independent groups to compare the efficacy of CFDC with the efficacy of the best available therapy for carbapenem-resistant A. baumannii infections. In contrast to the findings in the CREDIBLE-CR study, the 30-day mortality rates of the patients treated with CFDC were significantly lower than those in patients receiving best available therapy in both meta-analyses.
The international clinical trials of CFDC have evaluated the efficacy and safety of CFDC in only limited patient populations, thus making real-world evidence that includes diverse patients and evaluation of use in actual clinical practice valuable. However, real-world studies also have limitations, such as the lack of adjustment for patient background, and it is essential to interpret the results carefully.
Key word
cefiderocol, Acinetobacter baumannii, Gram-negative bacteria, carbapenem-resistant, real-world evidence
Received
January 21, 2025
Accepted
February 10, 2025
Jpn. J. Chemother. 73 (S-1): 54-61, 2025
