Image of Tsutae Nagata, M.D.

The new antibiotic cefiderocol is an effective option for treating patients with life-threatening drug-resistant infections, according to the results of a late-stage clinical trial.

Cefiderocol (Fetroja) was approved to treat a variety of infections by the Food and Drug Administration in November 2019. In the new trial, investigators examined its efficacy and safety against severe carbapenem-resistant Gram-negative infections. Participants included 152 hospital patients with healthcare-associated pneumonia, bloodstream infections or sepsis, or complicated urinary tract infections. 

Study cohorts received either three-hour intravenous cefiderocol infusions of two grams every eight hours or “best available therapy” for seven to 14 days. (In patients with pneumonia or bloodstream infection or sepsis, cefiderocol treatment could be combined with one among certain adjunctive antibiotics.)

Cefiderocol had similar effectiveness when compared with best available therapy, Japan-based drugmaker Shionogi concluded. Numerically more deaths occurred in the cefiderocol group, however, primarily in patients with Acinetobacter spp infections, which are a serious threat to the elderly. 

“Collectively, the findings from this study support cefiderocol as an option for the treatment of carbapenem-resistant infections in patients with limited treatment options,” concluded lead researcher Tsutae Nagata, M.D., chief medical officer, Shionogi.

The study was published in The Lancet.