2023-510220-72-00招募中4 期
PHARMACOLOGICAL STRATEGIES OF INHALED ANTIBIOTHERAPY IN BRONCHIECTASIS WITH CHRONIC BRONCHIAL INFECTION: BRONCHIPHARMA STUDY.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of colony forming units (CFU)
研究概览
简要总结
To evaluate if patients with chronic bronchial infection after receiving a course of targeted oral or intravenous treatment who subsequently receive treatment with inhaled antibiotics have a reduction in the colony-forming units compared to the placebo group.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients with bronchiectasis.
- •Age 20 to 90 years
- •Men and women alike.
- •Minimum of 2 sputum cultures positive for the same germ in the last year.
- •Under follow-up by the Multidisciplinary Bronchiectasis Unit of Hospital del Mar.
- •Severity of bronchiectasis and exacerbations according to the current scales: BSI, FACED, EFACED.
- •All patients who meet these criteria will be included regardless of their background treatment: Inhaled corticosteroids, bronchodilators, concomitant treatment with oral antibiotics such as azithromycin and whether or not they are receiving respiratory physiotherapy.
- •Provide signed and dated informed consent form.
- •Be willing to comply with all study procedures and be available during the duration of the study.
排除标准
- •Inhaled/nebulized antibiotic therapy in the last year
- •Adverse reactions to inhaled/nebulized antibiotics
- •Inability to use the nebulization device
- •Carriers of chronic home oxygen therapy
- •Concomitant infection with nontuberculous mycobacteria
- •In the case of women of childbearing age, a positive pregnancy test or desire for pregnancy during the period of the study
结局指标
主要结局
Number of colony forming units (CFU)
Number of colony forming units (CFU)
次要结局
未报告次要终点
研究者
Ana Maria Aldea
Scientific
Consorci Mar Parc De Salut De Barcelona
研究点 (1)
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