In Complicated UTI, Cefiderocol Noninferior to Imipenem-Cilastin
Results from phase 2 study in patients with multidrug-resistant Gram-negative uropathogens.
(HealthDay News) -- For complicated urinary tract infections caused by multidrug-resistant Gram-negative uropathogens, the siderophore cephalosporin cefiderocol is non-inferior to imipenem-cilastatin, according to a study published online Oct. 25 in The Lancet Infectious Diseases.
Simon Portsmouth, MD, from Shionogi Inc., in Florham Park, New Jersey, and colleagues conducted a phase 2 non-inferiority trial at 67 hospitals in 15 countries. A total of 452 patients admitted to the hospital with a clinical diagnosis of complicated urinary tract infection with or without pyelonephritis or with acute uncomplicated pyelonephritis were randomized to intravenous infusions of cefiderocol or imipenem-cilastatin every eight hours for seven to 14 days; 300 and 148 patients, respectively, received treatment. A total of 252 patients in the cefiderocol group and 119 patients in the imipenem-cilastatin group had a qualifying Gram-negative uropathogen and were included in the analysis of the primary end point of a composite of clinical and microbiological outcomes 7 days after cessation of treatment.
The researchers found that 73 and 55% of patients in the cefiderocol and imipenem-cilastatin groups, respectively, achieved the primary efficacy end point, with an adjusted treatment difference of 18.58%, establishing the noninferiority of cefiderocol. The patients tolerated cefiderocol well; adverse events occurred in 41 and 51% of patients in the cefiderocol and imipenem-cilastatin groups, respectively.
"As a siderophore antibiotic, cefiderocol is a novel approach that might be used to overcome Gram-negative resistance," the authors write.
The authors disclosed ties to Shionogi & Co. Ltd. and Shionogi Inc., which funded the study.