NCT01818206已完成不适用
Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage
研究概览
简要总结
Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Affiliated or benefit from a disease insurance regimen
- •Men and women
- •Aged from at least 6 years old
- •Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs.
- •Patients able to produce sputum
- •Pseudomonas aeruginosa Chronic infected patients
排除标准
- •Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents
- •Subjet in exclusion period
- •Law protected patient
- •Realisation of sputum production is contra-indicated
结局指标
主要结局
Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage
时间窗: after 6 hours in presence of bacteriophage
次要结局
- Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage(after 24 hours in presence of bacteriophage)
- Bacteriophage counts after 6 hours incubation within sputum samples(after 6 hours incubation within sputum samples)
- Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages(Sensitivity of individual PA colonies to bacteriophages)
研究者
研究点 (2)
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