A multicenter randomized controlled clinical trial of injectable ceftizoxime in the treatment of bacterial infections

ObjectiveTo evaluate the efficacy and safety of domestic injectable ceftizoxime in the treatment of bacterial infections.MethodsThe trial was designed as a randomized,double blind and multiple center study.Patients with respiratory or urinary tract bacterial infections were randomized into treatment group(A) or control group(B).Patients in the treatment group were treated with domestic injectable ceftizoxime 2.0 g,iv,q12 h,and patients in control group were treated with injectable ceftizoxime (Epocelin) 2.0 g,iv,q12 h,for 7-10 d(lower respiratory tract infections) or 5-14 d(urinary tract infections).ResultsA total of 144 patients(72 with respiratory tract infections,72 with urinary tract infections) were enrolled and completed the trial. There was no significant difference between the two groups in terms of basic clinical characteristics.The total clinical cure rate were 81.9% and 63.9% in A and B group respectively.The total clinical effective rate were both 98.6% in two groups.There was no significant difference(P0.05) between the two groups in terms of clinical efficacy.There was also no significant difference(100.0% vs 98.4%) between two groups with regard to bacterial eradication rate.The incidence of adverse reaction was 2.8% in the treatment group and 2.8% in control group(P(0.05)).No severe adverse reaction was found.ConclusionsDomestic injectable ceftizoxime is an effective and safe antibiotic for the treatment of lower respiratory tract and urinary tract bacterial infections.