EUCTR2013-004614-18-LT进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Neonates and infants up to 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 enrolment
- •- 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •· Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) less than 2/3 of normal for the applicable age group
- •· Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study.
研究者
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