A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 14
- 主要终点
- Number of Patients With Adverse Events (AEs)
研究概览
简要总结
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.
详细描述
This was a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). It could be combined with ampicillin and/or an aminoglycoside based on the Investigator's judgement according to manufacturer's instructions and/or local standard of care.
Following screening, ceftobiprole was administered as a 2-hour infusion at a dose of 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, depending on age and weight.
The target treatment duration was 3-10 days, which could be extended to 14 days if considered clinically necessary by the Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent from parent(s) or other legally acceptable representative (LAR) to participate in the study
- •Male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months
- •Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment
- •Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line
排除标准
- •Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment
- •Proven ventilator-associated pneumonia
- •Proven central nervous system infection (e.g., meningitis, brain abscess)
- •Proven osteomyelitis, infective endocarditis, or necrotizing enterocolitis
- •Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output < 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis
- •Progressively fatal underlying disease, or life expectancy < 30 days
- •Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication
- •Participation in another clinical study with an investigational product within 30 days of enrollment in the current study
研究组 & 干预措施
Treatment Arm: Ceftobiprole
Ceftobiprole medocaril: 7.5 mg/kg to 15 mg/kg
干预措施: Ceftobiprole medocaril (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs)
时间窗: Up to 5-7 weeks
Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest
次要结局
- Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite(On treatment Day 3 prior to and 2, 4, and 8 hours after the start of the first ceftobiprole infusion of the day)
- Number of Patients With a Clinical Response(Up to 28 days)
- Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)(Up to 28 days)
- Number of Patients With a Microbiological Response(Up to 28 days)