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临床试验/EUCTR2015-003662-87-DK
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

研究者

发起方
Aarhus University Hospital, Department of Respiratory Medicine

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