A Phase 3 randomized trial tested new antibiotic combinations against a standard treatment for complicated urinary tract infections and acute uncomplicated pyelonephritis. The study involved 614 adults across 79 sites in countries including Bulgaria, China, and Japan. Participants received either cefepime plus nacubactam, aztreonam plus nacubactam, or the standard combination of imipenem plus cilastatin.
Results showed that the cefepime-nacubactam group achieved clinical and microbiological success in 82% of patients. This was a 21.3% improvement over the standard treatment group, which saw success in 61% of patients. The aztreonam-nacubactam group also performed better than the standard treatment, with 72% success rates.
Safety data indicated that treatment-emergent adverse events occurred in 33% of patients on cefepime-nacubactam and 30% on aztreonam-nacubactam, compared to 43% on the standard treatment. No treatment-related deaths occurred. While these drugs offer potential options for resistant infections, readers should note this is a single trial and further research may be needed.