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临床试验/NCT00841971
NCT00841971已完成4 期

Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial

University of Pittsburgh6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
6
主要终点
Frequency of Fungal Infection

研究概览

简要总结

The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients

详细描述

A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.

Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.

Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.

Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.

The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Liver transplant recipient at increased risk for infection increased risk include any of the following:
  • retransplantation
  • renal replacement therapy (dialysis),
  • post transplant abdominal surgery (within 21days)
  • receipt of corticosteroids for greater than 14 days within the 4 weeks -preceding transplant
  • ICU care for greater than 48 hours at the time of transplantation
  • colonization with Candida sps within 4 weeks of transplantation
  • requirement of 15 units or greater of packed red cell transfusions
  • Intraoperative time exceeding 6 hours

排除标准

  • Hypersensitivity to azole or echinocandin antifungal agents
  • receipt of systemic antifungal therapy within 4 weeks prior to transplantation

研究组 & 干预措施

anidulafungin

Experimental

anti-fungal agent

干预措施: Anidulafungin (Drug)

Fluconazole

Active Comparator

anti-fungal agent

干预措施: Fluconazole (Drug)

结局指标

主要结局

Frequency of Fungal Infection

时间窗: 90 days post enrollment

次要结局

  • Need for Additional Antifungal Therapy(90 days post enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Singh

MD

University of Pittsburgh

研究点 (6)

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