A Phase 3, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Cefepime-AAI101 Compared to Piperacillin/Tazobactam in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,043
- 试验地点
- 24
- 主要终点
- Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC)
研究概览
简要总结
Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
cefepime/AAI101 combination
Cefepime 2 g in combination with AAI101 500 mg q8h (2 hour infusion)
干预措施: cefepime/AAI101 combination (Drug)
piperacillin/tazobactam
Piperacillin 4 g in combination with Tazobactan 500 mg q8h (2 hour infusion)
干预措施: Piperacillin/tazobactam (Drug)
结局指标
主要结局
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC)
时间窗: 7 days after EOT [±2 days] for patients receiving 7 days of treatment and 19 days after randomization [±2 days] for patients receiving more than 7 days of treatment.
Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication (\<103 CFU/mL in urine culture).
次要结局
- Proportion of patients in the m-MITT Population with overall treatment success at End of Treatment (EOT)(7 days for patients with cUTI only and up to 14 days for patients cUTI and blood stream infections)