[Translation] A phase II randomized, blinded, positive drug-controlled clinical trial on the safety and efficacy of amoxicillin sodium and clavulanate potassium for injection (10:1) in the treatment of bacterial infections
以注射用阿莫西林钠舒巴坦钠为对照药,评价国家化学药品注册分类3.2类新药注射用阿莫西林钠克拉维酸钾(10:1)治疗急性中、重度细菌感染(包括呼吸道感染、泌尿系统感染)的安全性和有效性,同时考察部分病例对阿莫西林耐药菌株所致感染的有效性。
[Translation] Using amoxicillin sodium and sulbactam sodium for injection as the control drug, the safety and efficacy of amoxicillin sodium and clavulanate potassium for injection (10:1), a new drug classified as 3.2 in the national chemical drug registration category, in the treatment of acute moderate to severe bacterial infections (including respiratory tract infections and urinary tract infections), and the effectiveness of this drug in some cases against infections caused by amoxicillin-resistant strains was also investigated.