EUCTR2016-002832-34-GB进行中（未招募）1 期
Aztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy. - AZTEC-CF
iverpool Heart & Chest Hospital0 个研究点目标入组 16 人开始时间: 2016年10月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- •Confirmed diagnosis of CF
- •Patients aged 18 - 65 years of age who have given informed consent
- •FEV1 >25% or <75% predicted (in keeping with Cayston® prescribing license)
- •Admitted to the Liverpool Heart and Chest Hospital with an exacerbation of CF pulmonary disease (as per modified Fuchs criteria)
- •Presence of Psa in lower respiratory tract cultures in the 6 months prior to screening
- •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 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Documented allergy to beta-lactam antibiotics or IV Colistin
- •Growth of Burkholderia Cepacia Complex (BCC) within 2 years
- •Previous organ transplant
- •Receiving other clinical trial medication
- •Already prescribed regular Cayston®
研究者
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