A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults

Wockhardt Bio AG0 个研究点目标入组 501 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Provide a signed written informed consent prior to any study-specific procedures
•2.Meet the following clinical criteria for either cUTI or AP:
•Have at least TWO of the following new-onset or worsening symptoms or signs:
•Fever (oral, tympanic, or rectal temperature >38Â°C [ >100.4Â°F]), which must be observed and documented by a health care provider Nausea or vomiting Dysuria, increased urinary frequency, or urinary urgency Lower abdominal, suprapubic, or pelvic pain
•Have at least ONE complicating factor
•B. AP, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least ONE of the following new-onset or worsening symptoms or signs:
•3. Evidence of pyuria within 48 h prior to randomization

•1.Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy.
•2.Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization
•3.Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period

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