EUCTR2006-005003-33-CZ进行中（未招募）不适用
Open label study of isavuconazole in the treatment of patients with aspergillosis and renal impairment or of patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi.
Basilea Pharmaceutica Ltd0 个研究点目标入组 100 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •1.Patients who have been fully informed and who have given voluntary written informed consent or whose legally authorized representative(s), have been fully informed and have given voluntary written informed consent if applicable,
- •Patients unable to write and / or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person.
- •2. Ability and willingness to complty with the protocol.
- •3. Male and female patients aged 18 years or over.
- •4.Female patients must be non-lactating and at no risk for pregnancy for one of the following reasons:
- •-Postmenopausal for at least 1 year
- •-Post hysterectomy and / or post-bilateral ovariectomy
- •-If of childbearing potential, having a negative urine or serum human chorionic gonadotropin (hCG) pregnancy test at Screening and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.
- •5.Patients who fall into one of the following 2 subgroups
- •a)Patients with proven or probable invasive aspergillosis who have renal impairment, defined as serum creatinine clearance < 50 ml/min at enrollment or patients on dialysis, and who require primary therapy.
- •NB: Patients fulfilling the criteria for possible” invasive aspergillosis who also have renal impairment will be eligible for enrollment; if, however, it is not possible to confirm the invasive aspergillosis as probable” or proven” by culture, histology / cytology or galactomannan (GM) antigen within 7 days after the first administration of study medication, the patient will be withdrawn from the study.
- •b) Patients with proven IFD caused by rare moulds, yeast, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida albicans) whether renally impaired or not who require salvage therapy for their IFD at the time of enrollment as defined below. Evidence of IFD based on respiratory samples may be acceptable after medical monitor’s approval.
- •See body of protocol for definitions of proven, probable and possible invasive aspergillosis and primary and salvage therapy.
- •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
- •1. Pregnant/ breastfeeding women.
- •2. Known history of allergy, hypersensitivity, or any serious reaction to the azole class of antifungals or to any component of the study medication.
- •3. High risk patients for QT/QTc prolongation e.g
- •-a family history of long QT syndrome, or,
- •-other known pro-arrythimic conditions.
- •4. Evidence of severe hepatic dysfunction with any of the following laboratory parameters at Screening:
- •- Total bilirubin 3 x upper limit of normal (ULN)
- •- Alanine transaminase or aspartate transaminase 5 x ULN.
- •5. Concomitant use of astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, cabamazepine, pimozide, quinidine, neostigmine or terfenadine in the 5 days prior to first administration of study medication.
- •6. Patients with chronic aspergillosis, aspergilloma, or ABPA.
- •7. Microbiological findings (e.g. virological) or other potential conditions that are temporally related and suggest a different etiology for the clinical features.
- •8. Advanced HIV infection with CD4 count <200 or acquired immunodeficiency syndrome-defining condition.
- •9. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy (e.g. neutropenia not expected to resolve, patients with endocarditis, osteomyelitis, meningitis, uncontrolled malignancy (treatment refractory, palliative therapy only) with life expectancy of less than 30 days).
- •10. Patients with concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she particiopate in the study.
- •11. Patients previously enrolled in a phase III study with isavuconazole, (NB patients may be transferred from study WSA-CS-004 if mycology identifies zygomycetes which is not expected to be susceptible to vuconazole).
- •12. Treament with any investigational drug in any clinical trial 30 days prior to the first administration of study medication except for unblinded phase III trials.
- •13. Patients unlikely to survive longer than 5 days.
研究者
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