A single-blinded multicenter randomized controlled clinical trial of ceftizoxime sodium for injection in the treatment of lower respiratory tract and urine tract infections

Objective To evaluate the efficacy and safety of ceftizoxime sodium for injection in the treatment of lower respiratory tract infections(LRTIs) and urinary tract infections(UTIs).Methods The trial was designed as a single-blinded,randomized and multicenter study.Patients with LRTI or UTI were randomized to receive ceftizoxime for injection or another ceftizoxime product as control.Patients in both groups received ceftizoxime 1-2g,q8-12h intravenously for 7 to 14 days.Results A total of 255 patients were enrolled in the trial and 243 subjects completed (122 in treatment group,121 in control group).The overall clinical effective rate was similar in the treatment and control groups(95.08% vs.95.87%,P0.05).The bacterial eradication rate was 98.78% and 98.84% respectively(P0.05).The incidence of adverse reaction was 8.59% and 19.69% respectively(P0.05).No serious adverse reaction was reported.Conclusions The tested ceftizoxime for injection is an effective and safe therapy for treating LRTIs and UTIs as controlled agent.