EUCTR2011-005799-41-GB进行中（未招募）不适用
Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and ofvoriconazole in patients with cystic fibrosis and presenting withpersistent positive sputums for Aspergillus - Azole Therapy in Cystic Fibrosis (ATCF)
CHU de Rennes (Rennes University Hospital Centre)0 个研究点目标入组 150 人开始时间: 2012年8月21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
- 150
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
- •- age greater than or equal to 18 years,
- •- patient with cystic fibrosis,
- •- presenting with a positive sputum culture for Aspergillus confirmed
- •twice : within 6 months entry and within 2 weeks of inclusion
- •- Written informed consent for adult patients.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •- patients with a contraindication to one of the antifungal agents
- •- pregnant women or nursing mothers,
- •- absence of an effective method of contraception in women of childbearing
- •- patients with signs or symptoms of invasive aspergillosis,
- •- patients with signs or symptoms of aspergilloma,
- •- patients with an infection caused by Burkholderia Cepacia complex or
- •mycobacteria,
- •- lung transplant patients, registered on a transplantation waiting list or
- •whose registration is imminent,
- •- patients who received systemic antifungal therapy for more than 5
- •days within 2 months prior to inclusion,
- •- patients currently enrolled in another clinical drug trial,
- •- ongoing treatment with medicinal products contraindicated with
- •itraconazole and voriconazole or with major interactions which reduce
- •azole concentrations,
- •- patients treated by medication known to prolong QT interval, or with
- •known prolongation of QTc interval > 450 msec in men and > 470 msec
- •- inability to follow or to understand the study procedures.
研究者
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