Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Duration in days of each asthmatic episode from randomisation start
研究概览
简要总结
Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the COPSAC2010 cohort
- •recurrent wheeze
- •and others
排除标准
- •Macrolide allergy
- •Heart, liver or kidney disease.
- •and others
研究组 & 干预措施
Antibiotics
Azithromycin (10 mg/kg once a day for 3 days)
干预措施: Azithromycin (Drug)
Placebo
Placebo mixture (once a day for 3 days)
干预措施: Placebo mixture (Other)
结局指标
主要结局
Duration in days of each asthmatic episode from randomisation start
时间窗: 1 to 3 years of age
Symptom scoring
时间窗: 1 to 3 years of age
次要结局
- Family's assessment of the episode(1 to 3 years of age)
- Asthma related health and economic assessment(1 to 3 years of age)
- MD assessment of the episode(1 to 3 years of age)
- need for PO steroids during the episode(1 to 3 years of age)
- beta-agonist use during the asthmatic episode(1 to 3 years of age)
- stratification of the above parameters according to bacterial colonisation of the airways(1 to 3 years of age)
- time lapse until the next asthmatic episode(1 to 3 years of age)
- percentage of time away from kindergarten or, for the parents, away from work(1 to 3 years of age)
研究者
Professor Klaus Bønnelykke
Professor
Copenhagen Studies on Asthma in Childhood