EUCTR2008-005037-30-ES进行中（未招募）1 期
FASE 2 DEL ESTUDIO PILOTO, QUE EVALUA LA INMUNOGENICIDAD Y LA SEGURIDAD DE IC43 EN PACIENTES EN LA UNIDAD DE CUIDADOS INTENSIVOS Original title: A PHASE 2 PILOT STUDY ASSESSING IMMUNOGENICITY AND SAFETY OF IC43 IN INTENSIVE CARE PATIENTS - IC43-201
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Intercell AG
- 入组人数
- 450
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
- •Male and female patients aged between 18 and 80 years.
- •Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
- •At high risk for acquiring infection against P. aeruginosa (i.e. previous treatment against P. aeruginosa, diminished lung function, high probability for requiring ventilation for more than 48 hours) at visit 0.
- •Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
- •In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception, as specified in protocol Section 6.4
- •Written informed consent (e.g. by the patient or legal representative) or waiver according to the national regulations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC43 vaccination at Visit 0
- •Low severity of illness defined by an acute physiology score < 8 at visit 0
- •Patients < 6 months post organ transplantation
- •Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
- •Pregnancy (positive pregnancy test at study entry), lactation
- •Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
研究者
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