EUCTR2015-003662-87-DK进行中(未招募)1 期
Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin
Aarhus University Hospital, Department of Respiratory Medicine0 个研究点开始时间: 2015年9月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, the patient must meet all of the following criteria:
- •·Signed informed consent to participate in the study in accordance with local
- •regulations
- •·Diagnosed with a chronic pulmonary disease by lung functions test or CT
- •·Diagnosed with one positive sputum sample with PA during the last year
- •·Age 18 - 85 years inclusive
- •·Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study
- •procedures specified in the protocol.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •·Prophylactic treatment with any other antibiotic
- •·Allergy to tazocin, ciprofloxacin or colistimethate-sodium
- •·Patients who are pregnant or planning a pregnancy
- •·Patients with any solid organ transplant
- •·Patients with cystic fibrosis
- •·Patients on assisted ventilation
- •·Bronchiectasis as a consequence of cystic fibrosis or focal endobronchial
- •lesion or otherwise curable causes (e.g. foreign body aspiration)
- •·Be considered terminally ill or listed for transplantation
- •·Actively treated Mycobacterium tuberculosis or other mycobacteria
- •·Patients in a condition or in a situation, which in the investigator's opinion
- •may put the subject at significant risk, may confound results or may interfere
- •significantly with the patient's participation in the study
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