Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline.
研究概览
简要总结
The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.
详细描述
To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following inclusion criteria:
- •Male or female children with ages from birth to younger than 12 years
- •Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection
- •Sufficient intravascular access
- •Negative urine pregnancy test
- •Written informed consent from parent(s)and verbal informed assent from subject
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- •Past or current history of epilepsy or seizure disorder
- •Moderate or severe renal impairment
- •If female, currently pregnant or nursing
- •Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level > 3 times upper limit of normal
- •Any condition that would make the subject, in the opinion of the Investigator, unsuitable for the study
- •Use of probenecid within 3 days prior to dosing
- •Receipt of a blood transfusion during the 24-hour period before enrollment
研究组 & 干预措施
Study of Blood Levels of Ceftaroline Fosamil
Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
干预措施: Ceftaroline fosamil (Drug)
结局指标
主要结局
Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline.
时间窗: Up to 5 days
This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported.
次要结局
未报告次要终点