Journal
CLINICAL INFECTIOUS DISEASES
Volume 72, Issue 12, Pages E1103-E1111Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciaa1799
Keywords
cefiderocol; complicated urinary tract infections; carbapenem-resistant infections; CREDIBLE-CR; mortality
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Cefiderocol has shown potential efficacy in treating complicated urinary tract infections and other related infections, but may lead to increased mortality in some cases, requiring further research.
In November 2019, the Food and Drug Administration (FDA) approved cefiderocol for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis caused by susceptible gram-negative bacteria in adults with limited to no alternative treatment options based on a randomized, double-blind, noninferiority cUTI trial (APEKS-cUTI). In a randomized, open-label trial (CREDIBLE-CR) in patients with cUTI, nosocomial pneumonia, bloodstream infections, or sepsis due to carbapenem-resistant gram-negative bacteria, an increase in all-cause mortality was observed in patients treated with cefiderocol as compared to best available therapy. The cause of the increased mortality was not established, but some deaths were attributed to treatment failure. Preliminary data from a randomized, double-blind trial (APEKS-NP) in patients with nosocomial pneumonia due to carbapenem-susceptible gram-negative bacteria showed a similar rate of mortality as compared to meropenem. We describe the uncertainties and challenges in the interpretation of the CREDIBLE-CR trial and some benefit-risk considerations for the use of cefiderocol in clinical practice.
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