EUCTR2021-002335-33-DE招募中1 期
Inhaled ColiFin® in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial - ERADICATE
Philipps University Marburg0 个研究点目标入组 66 人开始时间: 2021年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Age = 18 years at screening.
- •2.Bronchiectasis verified by chest CT scan.
- •3.New positive sputum culture for PA (not older than 12 weeks at screening).
- •4. 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.
- •5.Written informed consent.
- •6.Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) at screening,
- •7.WOCBP must agree to maintain a highly effective method of contraception during study treatment and at least 4 weeks thereafter.
- •Such methods include:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomised partner
- •sexual abstinence
- •8. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Bronchiectasis due to cystic fibrosis
- •2.Known prior infection with PA in the past 5 years before the new positive PA culture*
- •3.Treatment with pseudomonas-active antibiotics in the period between new PA positive sputum culture and baseline visit.
- •4.Planned pseudomonas-active antibiotic treatment during the time of study participation.
- •5. Any treatment with inhaled antibiotics or long-term pseudomonas-active treatment (=3 months) in the past 5 years before screening.
- •6. Known intolerance to ColiFin® in prior medical history.
- •7. Hypersensitivity/Known intolerance to Colistimethate sodium, Colistin, polymyxin B or to other polymyxins.
- •8. Known diagnosis of myasthenia gravis or porphyria
- •9. ppFEV1 < 30% (post-bronchodilator)
- •10. Pregnant women
- •11. Breast feeding women
- •12. strongly impaired renal function, GFR = 30 ml/min
- •13. Participation in any other interventional clinical trial
- •*Patients with a positive culture for PA from respiratory specimens within the past 5 years, but within a time frame of =3 years before new PA detection, who had at least 2 negative cultures for PA from respiratory specimens per year within these 3 years while not on pseudomonas-active treatment are also regarded as PA negative and can be included in the trial. Respiratory specimens include throat swab, sputum, tracheal/bronchial secretion and bronchial lavage fluid
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