[Translation] A randomized, double-blind, positive-controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of sequential treatment of (uncomplicated) acute pyelonephritis with amoxicillin sodium and clavulanate potassium (7:1) for injection
1.比较试验药注射用阿莫西林钠克拉维酸钾(7:1,每日两次给药)用于(非复杂性)急性肾盂肾炎与对照药注射用阿莫西林钠克拉维酸钾(5:1,每日三次给药)的疗效。
2.探索注射用阿莫西林钠克拉维酸钾(7:1)用于(非复杂性)急性肾盂肾炎治疗的远期疗效(临床复发、细菌复发),为后期确证性临床研究的设计提供科学依据。
[Translation] 1. To compare the efficacy of the experimental drug amoxicillin sodium clavulanate potassium injection (7:1, twice daily) for (uncomplicated) acute pyelonephritis with the control drug amoxicillin sodium clavulanate potassium injection (5:1, three times daily).
2. To explore the long-term efficacy (clinical recurrence, bacterial recurrence) of amoxicillin sodium clavulanate potassium injection (7:1) for the treatment of (uncomplicated) acute pyelonephritis, and provide a scientific basis for the design of subsequent confirmatory clinical studies.