EUCTR2010-023529-39-GB进行中（未招募）不适用
Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0
Southampton University Hopsitals NHS Trust0 个研究点开始时间: 2010年12月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Adolescents and young adults with cystic fibrosis aged 12 or above
- •Colonised with Pseudomonas aeruginosa (50% or more of all cultures in the last 12 months positive for Pseudomonas aeruginosa)
- •Criteria for randomisation:
- •Requiring antibiotic therapy for a pulmonary exacerbation:
- •A pulmonary exacerbation will be defined according to the criteria published by the 1994 cystic fibrosis foundation microbiology and infectious disease consensus and used in recent large clinical trials.
- •The presence of 3 of the following 11 criteria:
- •? Increased cough
- •? Increased sputum production, change in appearance of expectorated sputum production, or both
- •? Fever (greater than or equal to 38°C for at least 4 hrs in a 24 hrs period) on more than one occasion in the previous week
- •? Weight loss greater than or equal to 1kg or 5% of bodyweight associated with anorexia and decreased dietary intake
- •? School or work absenteeism (due to illness) in the previous week
- •? Increased respiratory rate, increased work of breathing, or both
- •? New findings on chest examination (e.g. rales, wheezing, crackles)
- •? Decreased exercise tolerance
- •? Decrease in FEV1 of greater than or equal to 10% from previous baseline study within the past 3 months
- •? Decrease in haemoglobin saturation (as measured by oximetry) from baseline value within past 3 months of greater than or equal to 10%
- •? New finding on chest radiograph
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Colonisation with Burkholderia Cepacia
- •Known hypersensitivity to the antibiotics used in the study
- •Other known contraindications to the antibiotics to be used in the study including known aminoglycoside related hearing/renal damage
- •Patients requiring non-invasive ventilation (NIV)
- •Patients who have a pneumothorax
- •Patients who are admitted for specific treatment of nontuberculous mycobacteria (NTM)
- •Patients who cannot tolerate nasal canula e.g. those who cannot breathe through their nose
- •Patients who have nasal polyposis that is causing significant blockage of the nasal passages
- •Adolescents who are not Gillick competent (and therefore not able to give their own assent in addition to parental consent)
- •Patients not likely to survive the time period of the study washout period (4 months from enrolment)
- •Treatment with an investigational drug or device within the last 3 months prior to enrolment
- •Patients who are pregnant (a pregnancy test will be carried out for females of 11 years and above as is standard practice for clinical trials)
- •Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted.
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