EUCTR2009-011346-26-IT进行中（未招募）不适用
A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis - BSYX-A110
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,550
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
- •In-patient at a Neonatal Intensive Care Unit (NICU) - Informed consent obtained from the legally authorized representative(s) - Less than 48 hours after birth at the time of initiation of first infusion - Birth weight of 600 grams to 1200 grams - Estimated gestation age ≤33 weeks as determined by the neonatologist - Existing intravenous access at the time of the first infusion - Infants from multiple births up to triplets may be included, but each infant must meet the inclusion/exclusion criteria and each infant will be individually randomized to a treatment group
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •- Proven staphylococcal sepsis as per this protocol prior to randomization - Concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk - Currently receiving, recently received, or planned to receive other agents (e.g., investigational or IVIG) that could interfere with the conduct, results or interpretation of this study - Severe congenital or chromosomal anomaly that would limit life expectancy or require corrective measures during the period of this study - Uncontrolled seizures
研究者
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