NCT00323986终止2 期
Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy. Effects on Recurrent Respiratory Infections, Inflammatory Parameters and Bacterial Persistence
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- reduction of number of exacerbations
研究概览
简要总结
Aims of the study
- to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
- to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses and steroid use.
- to evaluate the Quality of Life of patients treated and not treated with azithromycin, using a validate Italian version of St George questionnaire
- to evaluate the rate of chronic colonization with atypical pathogens
- to evaluate the safety and tolerability of a long-term treatment with azithromycin, including a survey on possible bacterial antibiotic resistance pattern variations
详细描述
Methods. Study Design Prospective, randomised, multicentre study. Centers
- Dott. E. Guffanti, IRCCS INRCA Casatenovo, Varese Italy
- Prof. F. Blasi, Università degli Studi di Milano, IRCCS Ospedale Maggiore Milan Italy
- Dott, M. Confalonieri, Ospedale Trieste, Italy Patients
We plan to enrol 30 patients :
Inclusion criteria
- Age > 45 years
- Tracheotomy
- History of COPD demonstrated by pulmonary function tests
- Informed Consent Exclusion criteria
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
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 45 years Tracheotomy History of COPD demonstrated by pulmonary function tests Informed Consent
排除标准
- •Allergy to macrolides Life expectancy < 1 year
结局指标
主要结局
reduction of number of exacerbations
reduction of number of hospitalisations
次要结局
- reduction of colony counts/eradication of bacteria on bronchial aspirates
- reduction of steroids and antibiotics use
- reduction of inflammatory cytokines in EBC
研究者
研究点 (6)
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