Effectiveness and Safety of Long-Term Intermittent Moxifloxacin Eradication Therapy in Non-Cystic Fibrosis Bronchiectasis: A 12-Month Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Exacerbation frequency
研究概览
简要总结
Bronchiectasis is a chronic respiratory disease characterized by recurrent infections, inflammation, and progressive lung damage. Frequent exacerbations are associated with increased morbidity, accelerated lung function decline, and reduced quality of life. Preventing exacerbations is a key therapeutic goal. Moxifloxacin, a fluoroquinolone antibiotic with broad-spectrum activity, may play a role in intermittent eradication therapy to reduce bacterial load, achieve microbiological clearance, and minimize exacerbation frequency.
This randomized controlled trial will evaluate the effectiveness and safety of long-term intermittent moxifloxacin therapy compared with standard care in patients with non-cystic fibrosis bronchiectasis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age.
- •Confirmed diagnosis of non-cystic fibrosis bronchiectasis by high-resolution CT (HRCT).
- •History of ≥2 bronchiectasis exacerbations in the previous 12 months.
排除标准
- •Diagnosis of cystic fibrosis-related bronchiectasis.
- •Known hypersensitivity or contraindication to fluoroquinolones (including moxifloxacin).
- •Severe hepatic impairment or severe renal impairment (eGFR <30 mL/min/1.73 m²).
- •Pregnancy or breastfeeding.
- •History of significant QT prolongation, arrhythmia, or concurrent use of QT-prolonging drugs.
- •Use of long-term suppressive antibiotics for bronchiectasis in the past 3 months.
研究组 & 干预措施
Intermittent Moxifloxacin + Standard Care
Participants will receive moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months) in addition to guideline-based standard care
干预措施: Intermittent Moxifloxacin + Standard Care (Drug)
Standard Care (Control)
Participants will receive guideline-based standard care without long-term suppressive antibiotics.
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Exacerbation frequency
时间窗: 12 months
Number of acute bronchiectasis exacerbations per patient during follow-up
次要结局
- Microbiological clearance(12 months)
- Change in FVC(Baseline and 12 months)
研究者
Montaser Gamal Ahmed
Lecturer of Chest Diseases and Tuberculosis
Assiut University