ISRCTN98785888已完成不适用
A double-blind, randomised, placebo-controlled phase III study of the efficacy of a bivalent Pseudomonas aeruginosa flagella vaccine in patients with cystic fibrosis
The Society for the fight of Cystic Fibrosis (The Gesellschaft zur Bekämpfung der Mukoviszidose e.V.) (Germany)0 个研究点目标入组 483 人开始时间: 2006年12月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 483
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Cystic fibrosis that has been diagnosed according to conventional criteria
- •2. Patients aged between two and 18 years
- •3. No infection with P. aeruginosa as assessed by a negative throat swab culture and negative serum antibody titres against the P. aeruginosa antigens exotoxin A
- •4. Alkaline protease and elastase in enzyme-linked immunosorbent assays (ELISAs)
- •5. A forced expiratory volume in one second (FEV1) of at least 70% of the predicted value
- •6. A weight-to-height ratio of at least 90%
- •7. An oxygen saturation of at least 92%
排除标准
- •1. A known allergy to thiomersal or mercury
- •2. A prolonged bleeding time or a pathological partial thromboplastin time (PTT) value
- •3. Were using immunosuppressive drugs such as systemic corticosteroids
- •4. Participating in other clinical studies
研究者
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