Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 12
- 主要终点
- Renal impairment/renal function deterioration
研究概览
简要总结
The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •At least 18 years old
- •Signature of ICF
- •Negative pregnancy test (women of child bearing potential)
- •Patients who comply with at least one of the following (A or B):
- •A: One of the following criteria (major criteria):
- •Re-transplant due to severe dysfunction of a previous hepatic graft
- •Requirement of any renal substitutive therapy, including dialysis or hemofiltration
- •Fulminant hepatitis requiring hepatic transplant
- •B: Two of the following criteria (minor criteria):
- •Post-transplant renal impairment (defined as CrCl< 50 mL/min) 30 days after transplantation
- •Intra surgery blood transfusion of at least 40 units
- •Choledochal jejunectomy
- •2 or more Candida sp cultures (nasal, pharynx, rectal) from 48 hours pre- to 48 hours post-hepatic transplant
- •Post transplant re-intervention (laparotomy)
排除标准
- •Hypersensibility to amphotericin B or candin
- •Patients who have received any other antifungal (excluding fluconazole or oral nystatin for a maximum of 7 days)
- •Documented or suspected fungal infection
- •Pregnant women of women who do not accept to us a valid anticonceptive method
- •Any other disease or medical condition that makes the patient not adequate to participate in the trial
研究组 & 干预措施
Anidulafungin
Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day.
干预措施: Anidulafungin (Drug)
Liposomal Amphotericin B
Liposomal amphotericin B once a day: 3 mg/kg/day
干预措施: Liposomal amphotericin B (Drug)
结局指标
主要结局
Renal impairment/renal function deterioration
时间窗: 14 days
Compare the development of renal imparment or deterioration of baseline renal function in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Number of infusion related adverse events
时间窗: 14 days
Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
次要结局
- Treatment discontinuation(14 days)
- Hepatic toxicity(14 days)
- Invasive fungal infection(Week 12 and week 24)
- Mortality(24 weeks post transplantation)