Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,055
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in one second (FEV1).
研究概览
简要总结
Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients. It was shown that this treatment taken every day or every week for 12 months, can improve the respiratory state of patients. From the second year of treatment, it would appear there is more profit to continue such treatment.
The main objective is to study the association between continuous use of azithromycin and lung function measured by Forced expiratory volume in one second (FEV1), after two years of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Cystic Fibrosis (whatever the genetic form)
- •Age ≥ 8 years
- •FEV ≥ 30% the year of azithromycin (N0)
- •Continuous treatment with azithromycin for at least 2 years.
排除标准
- 未提供
研究组 & 干预措施
Cystic fibrosis patients taking azithromycin
Cystic fibrosis patients taking azithromycin continuously for two years.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Forced expiratory volume in one second (FEV1).
时间窗: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
次要结局
- Body Mass Index (BMI)(yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin)
- Number of IV antibiotics cures(yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin)
- Pseudomonas aeruginosa colonization(yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin)