评价注射用阿莫西林钠克拉维酸钾(7:1)序贯治疗(非复杂性)急性肾盂肾炎的有效性、安全性的随机、双盲、阳性对照、多中心、II期临床研究
[Translation] A randomized, double-blind, positive-controlled, multi-center, phase II clinical study evaluating the effectiveness and safety of sequential treatment (uncomplicated) acute pyelonephritis with amoxicillin sodium and clavulanate potassium for injection (7:1)
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. Comparing the test drug amoxicillin sodium clavulanate potassium for injection (7:1, administered twice a day) for (uncomplicated) acute pyelonephritis with the control drug amoxicillin sodium clavulanate potassium for injection (5:1, administered three times a day).
2. To explore the long-term efficacy (clinical recurrence, bacterial recurrence) of amoxicillin sodium and clavulanate potassium for injection (7:1) in the treatment of (uncomplicated) acute pyelonephritis, and provide support for the design of later confirmatory clinical studies scientific basis.
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