Efficacy and safety of cefepime–nacubactam and aztreonam–nacubactam compared with imipenem–cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial

Key Points

• To assess the efficacy and safety of cefepime–nacubactam and aztreonam–nacubactam versus imipenem–cilastatin for complicated urinary tract infections and acute uncomplicated pyelonephritis.
• Phase 3 double-blind randomized trial
• Comparison of cefepime–nacubactam and aztreonam–nacubactam with imipenem–cilastatin
• Participants had complicated urinary tract infection or acute uncomplicated pyelonephritis.
• Cefepime–nacubactam significantly reduced infection rates compared to imipenem–cilastatin, with a p-value < 0.01.
• Aztreonam–nacubactam showed comparable safety profiles to imipenem–cilastatin.
• Overall, both experimental drugs demonstrated favorable efficacy profiles.