[Translation] A randomized, blinded, parallel-controlled, multicenter trial of meropenem for injection to evaluate the safety and efficacy of doripenem for injection in the treatment of complicated urinary tract infections
1.确证注射用多立培南在末次给药后7±2 天的临床疗效非劣于注射用美罗培南;2.评价末次给药后24 小时内的临床疗效;3.评价末次给药后24 小时内的微生物学疗效;4.评价末次给药后24 小时内的综合疗效;5.评价末次给药后14±2天的长期疗效或临床复发率;6. 评价注射用多立培南治疗复杂性尿路感染的安全性。
[Translation] 1. To confirm that the clinical efficacy of doripenem for injection is non-inferior to that of meropenem for injection 7±2 days after the last dose; 2. To evaluate the clinical efficacy within 24 hours after the last dose; 3. To evaluate the microbiological efficacy within 24 hours after the last dose; 4. To evaluate the comprehensive efficacy within 24 hours after the last dose; 5. To evaluate the long-term efficacy or clinical recurrence rate 14±2 days after the last dose; 6. To evaluate the safety of doripenem for injection in the treatment of complicated urinary tract infections.