A multicenter,double-blind,randomized controlled clinical trial of injectable cefoselis in the treatment of acute bacterial infections

Objective To evaluate the efficacy and safety of domestic injectable cefoselis in the treatment of acute bacterial infections.Methods A multicenter double-blind randomized controlled clinical trial was conducted. Patients with acute respiratory or urinary tract bacterial infection were randomized into treatment group or control group. Patients in treatment group were treated with injectable cefoselis. The patients in control group were treated with injectable cefepime. Both drugs were administered intravenously at a dose of 1-2 g twice daily for 7-14 days. Results A total of 241 patients (121 with respiratory tract infections,120 with urinary tract infections) were enrolled and completed the trial.The cure rate and efficacy rate were 60.2% and 96.7% in treatment group,and 54.2% and 94.9% in control group,respectively. The bacterial eradication rates in treatment and control groups were 94.4% and 100% respectively. There was no significant difference between the two groups (P0.05). The incidence of adverse reaction was 3.3% in treatment group,and 5.1% in control group. There was also no significant difference between the two groups (P0.05). No serious adverse reaction was reported. Conclusions Injectable cefoselis is effective and safe for the treatment of acute respiratory or urinary tract bacterial infections.