NCT00633126已完成1 期
Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy
Forest Laboratories3 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
详细描述
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
- •Body mass index (weight [kg]/height squared [m2]) of no more than 30
- •Males and females between 12 and 17 years of age, inclusive
排除标准
- •History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- •Past or current history of epilepsy or seizure disorder
- •Critically ill or unstable patients
研究组 & 干预措施
A
Experimental
ceftaroline
干预措施: ceftaroline (Drug)
结局指标
主要结局
The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.
时间窗: 12 hours after infusion
The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.
次要结局
- Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).(Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the HospitalInfectionsNCT01298843Forest Laboratories53
已完成
1 期
A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy SubjectsHealthyNCT01577589Pfizer34
进行中（未招募）
不适用
Study of Blood Levels of Ceftaroline fosamil in Children who arereceiving anitbiotic Therapy in the HospitalPharmacokinetics of a Single Dose of Ceftarolinefosamil in Children Ages Birth to Younger Than 12Years With Suspected or Confirmed InfectionMedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-002198-44-Outside-EU/EEACerexa, Inc. (subsidary of Forest Laboratories)56
Unknown
4 期
Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement TherapyInfection During Renal Replacement TherapyNCT02007122Medical University of Vienna25
已完成
1 期
Ceftaroline China Pharmacokinetics StudyHealthyNCT01458743Pfizer24