ACTRN12612000011886已完成4 期
A randomised, double blind, placebo controlled trial of Azithromycin versus Amoxycillin-Clavulanic Acid to treat mild to moderate respiratory exacerbations in children with non-Cystic Fibrosis bronchiectasis, Study One.
Qld Children's Medical Research Institute0 个研究点目标入组 189 人开始时间: 2012年1月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- o limit 至 19 Years（—）
- 性别
- All
入选标准
- •Aged less than 18 years.
- •Bronchiectasis, as defined by HRCT scan within the last 5-years OR followed by a respiratory physician for treatment of bronchiectasis if diagnosed earlier.
- •2 or more respiratory exacerbations of bronchiectasis symptoms in the 18 months prior to study enrolment.
排除标准
- •Cystic Fibrosis (defined as measurement of sweat chloride >35mmol/L or by gene mutation). Liver dysfunction. Severe (hypoxic, dyspnoea or hospitalisation required) or recent exacerbation (in the 4 weeks prior to study enrolment). Known hypersensitivity to penicillins or macrolides. Taking regular maintenance antibiotics of the same class as the investigational antibiotics (macrolides and penicillins), or has taken macrolides or penicillins in the 3 weeks prior to study enrolment. Current or recent (within 4 months prior to study enrolment) identification of pseudomonas organism in the airways.
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