2023-509277-22-00招募中2 期
Inhaled ColiFin® in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection – an open-label, proof of concept - randomized controlled trial (DZL-Eradicate)
Philipps-Universitaet Marburg12 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年9月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 12
- 主要终点
- Proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation
研究概览
简要总结
To evaluate the effect of ColiFin® therapy compared to SOC sputum/airway culture negativity for PA 28 weeks after randomization.
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
- •Age ≥ 18 years at screening
- •Bronchiectasis verified by chest CT scan
- •New positive sputum culture for PA (not older than 12 weeks at screening)
- •No recent onset of new respiratory symptoms or worsening of pre-existing respiratory symptoms (e.g. cough, sputum amount, sputum colour, sputum viscosity, haemoptysis, decreased exercise capacity, malaise, fatigue etc.) over the last 2 months before new positive PA sputum culture, as per investigator judgement
- •Written informed consent
- •Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) at screening
- •WOCBP must agree to maintain a highly effective method of contraception during study treatment and at least 4 weeks thereafter
- •Male subjects have to use condom during treatment and until the end of relevant systemic exposure in the male subject, plus a further 90-day period and non-pregnant WOCBP partner have to use any contraception method additionally
排除标准
- •Bronchiectasis due to cystic fibrosis
- •Pregnant women
- •Breast feeding women
- •strongly impaired renal function, GFR ≤ 30 ml/min
- •Participation in any other interventional clinical trial
- •Known prior infection with PA in the past 5 years before the new positive PA culture
- •Treatment with pseudomonas-active antibiotics in the period between new PA positive sputum culture and baseline visit
- •Planned pseudomonas-active antibiotic treatment during the time of study participation
- •Any treatment with inhaled antibiotics or long-term pseudomonas-active treatment (≥3 months) in the past 5 years before screening
- •Known intolerance to ColiFin® in prior medical history
- •Hypersensitivity/Known intolerance to Colistimethate sodium, Colistin, polymyxin B or to other polymyxins
- •Known diagnosis of myasthenia gravis or porphyria
- •ppFEV1 < 30% (post-bronchodilator)
结局指标
主要结局
Proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation
Proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation
次要结局
- Change in PA (semi-quantitative) in sputum from baseline to Day 29 of treatment
- Rate of pulmonary exacerbations in 28 weeks after randomisation
- Rate of severe exacerbations (hospitalizations) in 28 weeks after randomisation
- Time to first pulmonary exacerbation after start of treatment
- Change from baseline in respiratory symptom domain of the SGRQ ountil 28 weeks after randomization
- Change from baseline in quality of life measured by SGRQ until 28 weeks after randomization
- Change from baseline in quality of life measured by QOL-B until 28 weeks after randomization
- Change from baseline on change in ppFEV1
- Change in antibiotic susceptibility in isolated sputum PA until 28 weeks after randomization
研究者
Dr. Constanze C. Maresch
Scientific
Philipps-Universitaet Marburg
研究点 (12)
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