CTRI/2024/04/065043招募中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 Bacteriaincluding those with Underlying Kidney Dysfunction Precluding the Use of Colistin/Polymyxin B - No
Ms Wockhardt Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
研究者
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