Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Number of Participants with adverse drug reactions (ADRs)
研究概览
简要总结
The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan.
Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.
This study is seeking for patients with:
- sepsis (A very serious infection in your blood caused by germ (a bacteria)) or
- renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time.
Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received Zavicefta for the first time after the launch of Zavicefta
- •Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
- •Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
- •Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Avibactam sodium/Ceftazidime hydrate
Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta (Avibactam sodium/Ceftazidime hydrate) for the first time
干预措施: Avibactam sodium/Ceftazidime hydrate (Drug)
结局指标
主要结局
Number of Participants with adverse drug reactions (ADRs)
时间窗: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
次要结局
- Number of Participants with Clinical Effectiveness(From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued))
- Number of Participants with Clinical Effectiveness at the time of Test of Cure(28 days after the start of the administration)