CTRI/2024/04/065043已完成2 期
A Phase 2, Prospective, Multi-Center Study to Determine the Efficacy and Safety of Cefepime-Zidebactam (FEP-ZID) WCK 5222 for the Treatment of Adult Subjects with Serious Infections Caused by Carbapenem-Resistant Gram-Negative Bacteria including those with Underlying Kidney Dysfunction Precluding the Use of Colistin/Polymyxin B
Ms Wockhardt Limited18 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- To assess the clinical outcome of treatment with FEP-ZID at test of cure (TOC)
研究概览
简要总结
This is a Phase 2, Prospective, Multi-Center Study to Determine the Efficacy and Safety of Cefepime-Zidebactam (FEP-ZID) WCK 5222 for the Treatment of Adult Subjects with Serious Infections Caused by Carbapenem-Resistant Gram-Negative Bacteria including those with Underlying Kidney Dysfunction Precluding the Use of Colistin/Polymyxin B. Subjects providing informed consent and meeting all study eligibility criteria will be enrolled in the study FEP-ZID 3 g (2 g cefepime + 1 g Zidebactam).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female of 18 to 75 years of age. Provide a signed written informed consent prior to any study specific procedures. Meet the clinical criteria for Following infections caused by documented Carbapenem-Resistant Gram-negative Bacteria.
- •Hospital-acquired Bacterial Pneumonia (HABP)/Ventilator-associated Bacterial Pneumonia (VABP) ± concurrent Bloodstream Infection (ccBSI) or.
- •Complicated Intra-abdominal Infection (cIAI) ± ccBSI or.
- •Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ± ccBSI All females must have a negative Urine or Serum Pregnancy Test.
排除标准
- •Subjects with any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- •Receipt of potentially-effective systemic antibacterial therapy with potential activity against carbapenem-resistant Gram-negative bacteria within 48 hours during the 72 hours prior to treatment initiation.
- •Pregnant or breastfeeding women.
结局指标
主要结局
To assess the clinical outcome of treatment with FEP-ZID at test of cure (TOC)
时间窗: Test of Cure visit - Day 28
次要结局
- To evaluate percentage of subjects with clinical(cure, microbiological eradication, all-cause mortality (ACM), safety and tolerability)
研究者
研究点 (18)
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