An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 14
- 主要终点
- AUC0-last
研究概览
简要总结
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
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
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates and infants ≤3 months, with gestational age ≥28 weeks
- •Documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment
- •Expected to survive beyond the first 7 days after enrollment
- •Sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site
- •Parent's / legally acceptable representative's informed consent to participate in the study
排除标准
- •Major birth defect or malformation syndrome
- •Proven presence of an immunodeficiency
- •HIV or other congenital viral or fungal infection
- •Significant laboratory abnormalities including: hematocrit <20%; absolute neutrophil count <0.5x10⁹/L; platelet count < 50x10⁹/L; alanine aminotransferase or aspartate aminotransferase >3 times the age-specific upper limit of normal
- •Impaired renal function or known significant renal disease
- •Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
Ceftobiprole
Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for intravenous administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
干预措施: Ceftobiprole medocaril (Drug)
结局指标
主要结局
AUC0-last
时间窗: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)
Cmax
时间窗: Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The maximum observed plasma concentration (Cmax)
Tmax
时间窗: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The time of maximum observed plasma concentration (Tmax)
T>MIC of 4 mg/L
时间窗: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The duration of time after dose for which free-drug concentrations remained above a value of 4 mg/L (T\>MIC of 4 mg/L)
次要结局
未报告次要终点