Pilot Study: Efficacy of Caspofungin for Antifungal Prophylaxis for Selected High Risk Liver Transplant Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Invasive Fungal Infection Free follow-up
研究概览
简要总结
The aim of the study is to determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).
详细描述
The prophylactic use of anti-fungal drugs is crucial in order to decrease the incidence of invasive fungal infections in transplantation patients.
Invasive fungal infections (IFI) ---organ-related or systemic infections--- are in fact one of the most important causes of morbidity and mortality in patients undergoing solid organ transplantation (respectively, 70% and 100%).
The rationale of the proposed study is to evaluate a new protocol for the prevention of IFIs through the use of a newly introduced anti-fungal, caspofungin (commercial name: Cancidas), to be used for primary prophylaxis of fungal infections post-OLTx and to compare to drugs already in use (eg. amphotericin B, fluconazole), until 21 days after liver transplantation.
The aim of this study is determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).
The possibility of reducing the risk of fungal infections in liver transplant patients (usually between 7 and 42%) is therefore an important clinical goal.
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
- •patients shortlisted for liver transplantation
- •negative pregnancy test for fertile female patients 7 days prior enrollment
- •patients who can adequately communicate with study responsibles, who can understand and answer to protocol requirements
- •At least one of the following criteria:
- •MELD score ≥25
- •liver transplantation for acute liver failure
- •liver re-transplantation
- •fever without bacterial or viral infection
- •biliodigestive
- •re-laparatomy after LTx
- •post LTx pancreatitis
- •post LTx dialysis or renal insufficiency
排除标准
- •Patients enrolled in other clinical trial or those having received other experimental drugs 4 weeks prior to enrollment
- •Patients with a known fungal infection (based on the EORTC/MSG criteria)
- •Patients with history of hypersensitivity to the drug, or other counterindications
- •Patients with a diagnosed Severe Hepatic insufficiency (CTP >9)
- •Physical or hematochemical alterations
- •Clinically relevant psychological alterations in the 2 weeks preceding enrollment such as to interfere, in the researchers opinion, with the goal of the study
- •Patients being treated with Ciclosporin A
- •Subjects being removed from the trial shall be replaced.
研究组 & 干预措施
Caspofungin
Study group
干预措施: Caspofungin (Drug)
结局指标
主要结局
Invasive Fungal Infection Free follow-up
时间窗: 1 month
Invasive Fungal Infection free control 1 month after beginning treatment.
次要结局
- Study group mortality(3 months)
- Tolerance to treatment.(3 months)
- Study group morbidity(3 months)
- Invasive Fungal Infection-free percentage of study group(1 month)
研究者
Prof. Umberto Cillo
Director of the Hepatobiliary Surgery and Liver Transplantation Unit
Azienda Ospedaliera di Padova