EUCTR2006-001146-13-DE进行中（未招募）1 期
Investigation of Caspofungin Plasma Concentration and Pharmacokinetic for the Improvement of the Antifungal Therapy in Patients of Surgical Intensive Care Unit - CASPO-PK-Intensiv
niversity Hospital of Heidelberg0 个研究点目标入组 50 人开始时间: 2006年3月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Age > 18 years
- •Patients of intensive care unit with proven or probable invasive fungal infections caused by candida or aspergillus species who are treated with Caspofungin as a regular treatment during hospitalisation.
- •Precautions, special warnings, interactions containing in the Fachinformation (SPC) have to be followed.
- •Decision for dosage and dose adjustment because of insufficient activity, adverse effect, interactions, organ dysfunctions or body weight should only be made after benefit-risk-estimation.
- •concomitant application of Ciclosporin A, Tacrolimus or Rifampicin and close monitoring of drug levels and liver functions.
- •Voluntarily signed informed consent after full explanation of the study to the patients.
- •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
- •Hypersensitivity against Caspofunginacetate or other constituents
- •Patients with severe liver dysfunction
- •concomitant application of Ciclosporin A, Tacrolimus or Rifampicin without close monitoring of drug levels and liver functions.
- •Patients who get Caspofungin less than 10 days.
- •In case of contraindications containing in the Fachinformation (SPC).
研究者
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