background
Carbapenem-resistant Enterobacteriaceae and multidrug-resistant Pseudomonas aeruginosa pose a global health threat. Cefepime-taneborbactam is an investigational beta-lactam and beta-lactamase inhibitor combination active against Enterobacteriaceae and Pseudomonas aeruginosa expressing serine and metallo-beta-lactamases .
method
In this randomized, double-blind, phase 3 trial, we assigned hospitalized adults urinary tract infection (UTI), including acute pyelonephritis, intravenous cefepime-taniborbactam (2.5 g) or meropenem (1 g) in a 2:1 ratio every 8 hours for 7 days; if bacteria develop blood, this duration may be extended to 14 days.
he main ending It is microbiological and clinical success (composite success) achieved on days 19 to 23 of the trial in the microbiological intention-to-treat (microITT) population (patients with qualifying Gram-negative pathogens and both study drugs are active). After confirmation of non-inferiority, a prespecified superiority analysis was performed on the primary outcome.
result
Of 661 patients who underwent randomization, 436 (66.0%) were included in the microITT population. The average age of patients was 56.2 years, with 38.1% being 65 years or older. In the microITT population, 57.8% of patients had complicated urinary tract infection, 42.2% had acute pyelonephritis, and 13.1% had bacteremia.