Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 26
- 主要终点
- Absence of breakthrough proven/probable invasive fungal infection by day +100
研究概览
简要总结
This is a non-comparative, open, multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection. It is expected that the proportion of high-risk liver transplant recipients who develop a documented (proven or probable per European Organization for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG] modified criteria) invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It is also expected that the incidence of serious drug-related adverse events will be less than 25%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Patient has received an orthotopic liver transplantation
- •Patient meets criteria, as defined per protocol, for being considered at high risk of developing an invasive fungal infection post-liver transplantation
- •For women of childbearing potential, patient must have a negative serum or urine pregnancy test
排除标准
- •Any systemic antifungal therapy (other than fluconazole for a maximum of 7 days) within 14 days of the administration of the study drug.
- •Documented (proven/probable) or suspected (possible) invasive fungal infection at the time of enrollment.
- •Abnormal laboratory values as defined per protocol.
- •Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal.
- •Patient not expected to survive at least 5 days.
- •Patient is pregnant or breast feeding.
结局指标
主要结局
Absence of breakthrough proven/probable invasive fungal infection by day +100
次要结局
- Absence of breakthrough proven/probable invasive aspergillosis by day +100
- Discontinuation of study therapy due to a drug-related adverse event
- Incidence of drug-related serious adverse event(s)
- Incidence of drug-related adverse event(s)