Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: a Randomized Controlled Trial on Azithromycin (AZI) for Airway Infection Prevention
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Incidence of exacerbations
研究概览
简要总结
Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed.
The link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. Although antibiotics can alleviate symptoms, relapse is common.
Experts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population.
To address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. This research aims to inform clinical practice and improve the health of affected children and their families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT and bronchoscopy verified and structural lung damage or congenital lung and airway malformations
- •Outpatient affiliation with one of the three highly specialized pediatric pulmonology centers.
- •At risk of or already documented respiratory infections requiring antibiotics.
- •Age between 0-72 months at inclusion.
排除标准
- •Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study.
- •Cystic fibrosis (CF) or primary ciliary dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded.
- •Impaired liver function: Children with an alanine transaminase (ALAT) twice or more the upper limits of normal will be excluded.
- •Impaired kidney function: Children with a serum creatinine higher than the upper limit of normal for age will be excluded.
- •Neurological or psychiatric disorders
- •Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded.
- •Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study.
- •Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study.
研究组 & 干预措施
Azithromycin Oral Suspension 40 mg/ml
干预措施: Azithromycin 40 MG/ML (Drug)
Placebo Oral suspension
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of exacerbations
时间窗: 6 months
Number of exacerbations where systemic antibiotics is needed within the study period
次要结局
- Severity of exacerbations(6 months)
研究者
Marika Nathalie Schmidt
Principal investigator
Rigshospitalet, Denmark