Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program (PERSEUS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 55
- 主要终点
- Rate Of Clinical Success
研究概览
简要总结
The aim of this study is to describe the use of cefiderocol in the management of Gram-negative infections (GNIs) in participants treated through the Early Access Program (EAP) in Spain.
详细描述
This is a multicenter, retrospective, chart review of existing medical records in participants who received cefiderocol for a GNI as part of the Shionogi EAP. Access to cefiderocol was granted as Medication not approved in Spain subject to RD 1015/2009, which dictates that each case is approved on an individual basis by the Spanish Agency of Medicines. This study will be conducted at Spanish sites where cefiderocol was supplied via the EAP, beginning in 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Have received first course of cefiderocol.
- •Have received treatment for at least 72 hours (complete) with cefiderocol as a part of clinical compassionate management, requested in the EAP.
排除标准
- •Enrolled in any clinical trial of an investigational product.
- •Documented Acinetobacter spp infection.
- •Incomplete medical records for the following essential data elements:
- •Cefiderocol usage (dose, duration, frequency)
- •Data to be able to determine clinical success (primary objective)
- •Co-infection with a GNB resistant to cefiderocol in 28 days of the initial dose of cefiderocol.
研究组 & 干预措施
Cefiderocol Treated
Participants who have been treated with at least 72 hours of cefiderocol through the EAP in Spain.
干预措施: Cefiderocol (Drug)
结局指标
主要结局
Rate Of Clinical Success
时间窗: From Day 1 (cefiderocol initiation) through Day 28
The rate of clinical success will be reported as the percent clinical success of participants treated with cefiderocol for participants who receive at least 72 hours of cefiderocol through the EAP for the treatment of Gram-negative, carbapenem-resistant infections (except for Acinetobacter spp).
次要结局
- Length of Stay in Intensive Care Unit (ICU)(Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first))
- Rate of Microbiological Eradication(Day 1 (24 hours post cefiderocol initiation) through Day 28)
- Number of Participants Experiencing Resolution of Infection or Clinical Cure After Treatment With Cefiderocol(Day 1 (cefiderocol initiation), every 7 days up to Day 28)
- In-hospital Length of Stay(Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first))
- Number of Participants Experiencing Resolution of Infection or Clinical Cure After Prolonged Treatment With Cefiderocol(Day 1 (cefiderocol initiation), every 10 days up to Day 60)
- Length of Invasive Ventilation(Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first))
- Cause of Death(Day 1 (cefiderocol initiation) through Day 28)
- All-cause In-hospital Mortality(Day 14, Day 28)
- Number of Participants With Adverse Drug Reactions (ADRs)(Up to 28 days post-treatment completion with cefiderocol, death, or discharge (whichever occurs first))
- Severity of Illness(Day 1 (cefiderocol initiation) through Day 28)