Open-label, randomised, controlled study to compare the efficacy and safety of cefepime/sulbactam and cefepime in patients with acute pyelonephritis

Aim

To compare the efficacy and safety of cefepime/sulbactam and cefepime in patients with acute pyelonephritis.

Material and methods

Males and females aged of 18 to 65 years with acute pyelonephritis were randomised into two groups and treated with intravenous cefepime/sulbactam or cefepime 2 g every 12 hours for 7 to 14 days.

Results

Ninety seven patients were enrolled in the study. Ninety six of them completed the treatment according to the protocol. At baseline, the most common identified uropathogens included E. coli (67.0%), E. faecalis (7.2%), K. pneumoniae (3.0%), P. aeruginosa (2.0%). The average duration of treatment was 7.65±1.00 и 7.54±0.62 days in the two groups, respectively. In per-protocol population, the efficacy (clinical recovery and eradication of uropathogen) of cefepime/sulbactam and cefepime was 97.9% and 95.8%, respectively (p>0.05). Both drugs were safe and well-tolerated.

Conclusion

Cefepime/sulbactam was at least as safe and effective as cefepime in patients with pyelonephritis.

Key words

Cefepime, sulbactam, pyelonephritis