A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Bacterial Clearance Rate of Sputum
研究概览
简要总结
This is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.
详细描述
Objective
To assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.
Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum.
Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female study subjects ≥18 years of age and ≤80 years of age;
- •Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis;
- •Confirmation of infection with Pseudomonas aeruginosa at screening;
- •Are sensitive to amikacin;
- •Acute exacerbation of bronchiectasis.
排除标准
- •Bronchiectasis due to special causes;
- •Are associated with bronchial asthma;
- •Have any serious or active medical or psychiatric illness;
- •Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after inhaling amikacin.
研究组 & 干预措施
Nebulized amikacin
Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.
干预措施: Amikacin (Drug)
Nebulized normal saline
Participants received nebulized normal saline BID for 14 days in combination with standard treatment.
干预措施: Normal saline (Drug)
结局指标
主要结局
Bacterial Clearance Rate of Sputum
时间窗: after 14 days
The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having ≥25 white blood cells/highpower field and ≤10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated.
次要结局
- Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment(after 14 days)
- Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment(after 14 days)
- Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment(after 14 days)
- Sputum Property Score After 14 Days of Treatment(after 14 days)
研究者
Qian Qi
assistant director
Qilu Hospital of Shandong University