EUCTR2006-001936-30-DE进行中（未招募）不适用
A phase II dose escalation study of caspofungin in patients with invasive aspergillosis - Caspofungin MTD
niversität zu Köln0 个研究点目标入组 48 人开始时间: 2006年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •Adults =18 years
- •Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (=20 mg Prednisone or equivalent for = 3 weeks), treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections (IFIs).
- •Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria.
- •Female patients of childbearing age must have a negative pregnancy test at study entry and take adequate contraceptive measures throughout the study.
- •Written informed consent given by the patient or his/her legal guardian prior to enrollment in the study.
- •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
- •Pregnant or breast-feeding female patients.
- •Patients with the following pathological laboratory findings:
- •oSerum bilirubin > 3x upper limit of the age-adjusted normal range
- •oSGOT or SGPT > 5x the upper limit of the age-adjusted normal range
- •oAlkaline phosphatase > 5x the upper limit of the age-adjusted normal range
- •Patients who have undergone hematopoietic stem-cell transplantation with clinical or laboratory evidence of active veno-occlusive disease (VOD). VOD is characterized by early elevation of serum transaminases and subsequent persistent elevation of serum bilirubin, tenderness of the liver, increase in body weight, and ascites.
- •Hemodynamically unstable patients or patients with an expected survival time of <5 days.
- •Patients previously enrolled in the study.
- •Patients with concomitant diseases or conditions which, in the opinion of the principle investigator, could distort the results of the study or which could entail an additional risk for a patient receiving the study medication.
- •Patients concurrently receiving efavirenz, nevirapin, rifampicin, dexamethasone, phenytoin, carbamazepine, phenobarbital or cyclosporin A. Topical use of dexamethasone, e.g. as eye drops, is allowed.
- •Patients with a documented history of intolerance to echinocandin antifungal agents.
- •Concomitant other systemic antifungal agents are not permitted on study.
- •Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study
- •Prior systemic therapy of = 4 days with any polyene anti-fungal agent within 14 days of study enrollment
- •Prior systemic therapy of = 4 days with non-polyenes (i.e., azole or echinochandin derivatives) for the current, documented IFI. (Prior systemic anti-fungal therapy with azole derivatives for prophylaxis or as empiric therapy for febrile neutropenia is permissible. Fluconazole is permissible.)
研究者
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