[Translation] A randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter clinical study on the safety and efficacy of doripenem injection in the treatment of complicated urinary tract infections
主要目的:证明注射用多立培南在末次给药后6到8天的临床疗效非劣于注射用美罗培南。次要目的:评价末次给药后6-8天的微生物学疗效、末次给药后6-8天的综合疗效、末次给药后24小时内的临床疗效、末次给药后24小时内的微生物学疗效、末次给药后24小时内的综合疗效、末次给药后13-15天的长期疗效或临床复发率。
[Translation] Primary objective: To demonstrate that the clinical efficacy of doripenem for injection is non-inferior to that of meropenem for injection 6 to 8 days after the last dose. Secondary objectives: To evaluate the microbiological efficacy 6-8 days after the last dose, the comprehensive efficacy 6-8 days after the last dose, the clinical efficacy within 24 hours after the last dose, the microbiological efficacy within 24 hours after the last dose, the comprehensive efficacy within 24 hours after the last dose, the long-term efficacy or clinical relapse rate 13-15 days after the last dose.