A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 3
- 主要终点
- Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
研究概览
简要总结
This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia 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 Community Acquired Bacterial Pneumonia (CABP)
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 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 CABP requiring hospitalization and IV antibacterial therapy
排除标准
- •Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
- •Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
- •Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
- •Non-infectious causes of pulmonary infiltrates.
研究组 & 干预措施
Ceftaroline fosamil
干预措施: Ceftaroline fosamil (Drug)
Ceftaroline fosamil
干预措施: amoxicillin clavulanate (Drug)
Ceftriaxone
干预措施: Ceftriaxone (Drug)
Ceftriaxone
干预措施: amoxicillin clavulanate (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
时间窗: Between 1 and 50 days.
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with CABP. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), vital signs.
次要结局
- Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.(Between 4 and 50 days)
- To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.(Between 4 and 50 days)