A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 71
- 主要终点
- Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
研究概览
简要总结
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
详细描述
To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 2 months to < 18 years old.
- •Presence of ABSSSI warranting initial hospitalization.
- •Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention
排除标准
- •Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
- •Uncomplicated skin and soft tissue infections
- •More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.
- •Requirement for any concomitant systemic antimicrobial therapy
- •History of seizures, excluding well-documented febrile seizure of childhood.
- •Clinical signs or suspicion of meningitis
研究组 & 干预措施
Ceftaroline fosamil
干预措施: Ceftaroline fosamil (Drug)
Ceftaroline fosamil
干预措施: Cephalexin or Clindamycin or Linezolid (Drug)
Comparators
Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
干预措施: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam (Drug)
Comparators
Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
干预措施: Cephalexin or Clindamycin or Linezolid (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
时间窗: Between 26 and 50 days.
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group.
次要结局
- Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.(Between 1 and 5 days)
- Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.(Between 1 and 5 days)