A multicentre, double-blind, randomised clinical trial of parenteral cefepime in the treatment of acute bacterial infections

Abstract number: 1733_350

Lu X.J.

Objective: To evaluate the clinical efficacy and safety of domestic injectable cefepime for the treatment of acute moderate and severe bacterial infections.

Methods: A multicentre double-blind randomised clinical trial was conducted comparing the efficacy and safety of domestic injectable cefepime with imported one (Maxipime). Cefepime was administered intravenously at a dose of 1–2 g twice daily for 7 to 14 days.

Results: A total of 211 patients were enrolled in the study. There were 109 patients who enrolled in FAS analysis and 104 in PPS analysis in treatment group, while 108 patients were enrolled in FAS analysis and 107 patients were eligible for PPS analysis in control group. At the end of treatment, the cure rate and effective rate were 42.30% and 84.61% in trial group; while 48.59% and 79.43% in control group. The bacterial eradication rates were 91.3% and 86.7%, respectively. There was no statistical difference between the two groups (P > 0.05). Adverse reactions were observed in 8.93% and 5.41% of patients in the two groups, dominated by skin rash (1/112), temporary acidophilia (2/112; 2/111) and mild elevated transaminases (4/112; 2/111).

Conclusion: Domestic injectable cefepime is effective and safe for the treatment of acute moderate and severe bacterial infections.